11.0.x Solution Packages Installation Checklists · Equipment Calibration Installation and Configuration Checklist.....259 Section 17: Equipment Maintenance ... 3.2. Pre-Installation

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Installation and Configuration

Checklists

for

MasterControl Solution Packages

Vers ion 11 .4

Prepared by MasterControl, Inc.

Copyright© 2015, MasterControl, Inc. All Rights Reserved

May not be reproduced without permission.

ii

Table Of Contents

Section 1: Accident & Injury ................................................................. 1

Accident & Injury Installation and Configuration Checklist ............................... 2

Section 2: Action Item ......................................................................... 11

Action Item Installation and Configuration Checklist ...................................... 12

Section 3: Audit Essentials ................................................................. 20

Audit Essentials Installation and Configuration Checklist .............................. 21

Section 4: CAPA Advanced ................................................................ 43

CAPA Advanced Installation and Configuration Checklist ............................. 44

Section 5: CAPA Essentials ................................................................ 59

CAPA Essentials Installation and Configuration Checklist ............................. 60

Section 6: Change Control Advanced ................................................ 73

Change Control Advanced Installation and Configuration Checklist .............. 74

Section 7: Clinical CAPA ..................................................................... 88

Clinical CAPA Installation and Configuration Checklist .................................. 89

Section 8: Clinical Deviation ..............................................................102

Clinical Deviation Installation and Configuration Checklist........................... 103

Section 9: Clinical Site Closeout .......................................................117

Clinical Site Closeout Installation and Configuration Checklist .................... 118

Section 10: Clinical Site Initiation .......................................................129

Clinical Site Initiation Installation and Configuration Checklist ..................... 130

Section 11: Clinical Site Interim ..........................................................152

Clinical Site Interim Installation and Configuration Checklist ....................... 153

Section 12: Customer Complaint Advanced .......................................179

Customer Complaint Advanced Installation and Configuration Checklist .... 180

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Section 13: Customer Complaint Essentials ......................................204

Customer Complaint Essentials Installation and Configuration Checklist .... 205

Section 14: Deviation ...........................................................................220

Deviation Installation and Configuration Checklist ....................................... 221

Section 15: eMDR .................................................................................237

eMDR Installation and Configuration Checklist ............................................ 238

Section 16: Equipment Calibration......................................................258

Equipment Calibration Installation and Configuration Checklist ................... 259

Section 17: Equipment Maintenance ...................................................268

Equipment Maintenance Installation and Configuration Checklist ............... 269

Section 18: Extension Request ...........................................................281

Extension Request Installation and Configuration Checklist ........................ 281

Section 19: HR/Finance ........................................................................291

HR/Finance Installation and Configuration Checklist ................................... 292

Section 20: Incident Reporting ............................................................307

Incident Reporting Installation and Configuration Checklist ......................... 308

Section 21: Meeting Notes ...................................................................323

Meeting Notes Installation and Configuration Checklist ............................... 324

Section 22: Nonconformance ..............................................................335

Nonconformance Installation and Configuration Checklist ........................... 336

Section 23: Out-of-Specification (OOS) ..............................................354

Out-of-Specification Installation and Configuration Checklist ....................... 355

Section 24: Risk Analysis ....................................................................372

Risk Analysis Installation and Configuration Checklist ................................. 373

Section 25: Supplier Corrective Action ...............................................381

Supplier Corrective Action Installation and Configuration Checklist ............. 382

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Section 26: Supplier Deviation ............................................................393

Supplier Deviation Installation and Configuration Checklist ......................... 394

Section 27: Supplier Scorecard ...........................................................410

Supplier Scorecard Installation and Configuration Checklist........................ 411

Section 28: Variance.............................................................................421

Variance Installation and Configuration Checklist ........................................ 422

1

Accident & Injury

2

Accident & Injury Installation and Configuration Checklist

1. Overview: Accident & Injury

This document is intended to guide users through the process of installing and/or configuring the MasterControl Accident & Injury Solution.

IMPORTANT:

Any modification in excess of the configuration options presented in the checklists below is considered customization. Customization may require an update of other documentation (such as the Operational Qualification, Functional Requirements Specification, Standard Operating Procedures, etc.).

2. Completion Signature

Signature Title Date

3. Prerequisites and General Considerations

3.1. Installation into a Previously Configured Environment

MasterControl version 11.x contains an easy to use installation mechanism for solution packages and their associated menu items. The installation is triggered manually in order to safeguard existing configurations.

The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes, and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with: “_LOAD”

In such cases, the newly created records need to be manually reconciled with the existing configuration. Consult section 5 for a list of records that the installer will place in the system.

Following are recommendations for installation into an environment with pre-existing records:

- First, always install the solution package in a test environment that mirrors the production system. This allows system administrators to work out the procedure for updating the production system, minimizing the impact to existing data and records.

- It is recommended to use the records installed through the install mechanism and retire the duplicated existing records. This will minimize the impact of any future upgrades.

3

3.2. Pre-Installation Checklist

Instruction Status

Verify the installation environment is MasterControl Portal version 11.0.x or higher.

Version requirements are met. The installation environment version is:

Identify the URL to the login screen of the target system.

System Identified

4. Installation Procedure

Instruction Status

Log into the system as Sysadmin or another user with the appropriate rights to perform solution package installations.

Go to Process > Solution Packages to view the Solution Package(s) available for installation in your system.

Select the following Solution Package(s) to install:

Accident & Injury Complete

Already installed

The following other form process is included in this solution as a required add-on and needs to be installed prior to use:

Extension Request (see the “Extension Request Installation and Configuration Checklist” section in this manual for installation detail)

Complete

Already installed

Always select Template Mappings from the list. This will update template mappings for the solutions you are installing.

Template Mappings

Complete

If Data Structures have not been previously installed, select Data Structures as well.

Data Structures

Complete

Already installed

Click Save. It may take several minutes to complete the installations. Installation complete

4

Instruction Status

Not Yet Completed (add to Open Items, section 6)

Go to Portal > Configuration > Custom Menus to view a list of available menus to install.

Install the SP_SA_Accident_&_Injury_Menu.xml. This will create a standalone menu for this solution.

The Event Analyzer menu item gives access to the Event Analyzer and reports based on EventCards to enable advanced monitoring and analytics. It is recommended to install this menu if it has not already been installed.

IMPORTANT NOTE:

You may receive an error notification stating that a dataset specified in the menu does not exist in your target system. Creation of the dataset is triggered by the previous installation step and may take up to 30 minutes to complete, depending on server load and the number of solutions being installed. If you encounter this error, please try again after an adequate amount of time.

Menu(s) installed:

Complete

If the default or test users are to be used for the purpose of testing or validation, then create the users as follows:

Install Test Users:

Go to Portal > Loading > Users to view a list of available users to install. To choose which users to install, refer to the Default column below. Select those users on the Loading > Users window in MasterControl. It may take several seconds to complete the installation.

Verify association of Test Users with their Roles:

Go to Portal > User Management > Roles. Click the Edit icon next to each role, and in edit security role window, make sure that the test users have been associated with their appropriate roles as indicated in the Default column below.

If the default or test users are not to be used, then:

Associate your own users to their appropriate roles, and list them in the Custom column, below, next to the roles.

Enable the route:

Go to Process > Routes. In the Route Name column, locate Accidents & Injury.

Complete

5

Instruction Status

In the Actions column of the Accidents & Injury row, click the Enable Route icon (green check mark) to enable the route.

A blue checkmark appears in the Status column.

Default Custom

Safety Coordinator (SP_AIN_SafetyCoordinator)

AIN_User1

Medical Representatives (SP_AIN_MedicalReps)

AIN_User2

AIN_User3

Extension Request Approvers (SP_AIN_ExtReqApprovers)

AIN_User4

AIN_User5

Subadmin (SP_Subadmin)

SPSUBADMIN_User1

Safety Coordinator (SP_AIN_SafetyCoordinator)

___________________________

___________________________


___________________________

___________________________

___________________________


___________________________

___________________________

___________________________


___________________________

___________________________

___________________________

The installed form(s) processes are now usable with default configuration options.

If configuration is required, complete section 4.1, Post-Installation Configuration.

Installation is Complete

Post-Installation Configuration is Required

Notes

6

4.1. Post-Installation Configuration

Instruction Status

Locate the template created by the installer (numbering series SP-FRM-xxxx).

Template InfoCard Number and Revision:

SP-FRM- Rev

This template does not need to be modified.

Complete

N/A

To dynamically populate a data structure’s drop-down options from an outside source, click the Edit Data Structure icon next to the data structure. Change the Data Structure from “Internal” to “External” and fill out the relevant information. For more information on creating external data structures, consult the MasterControl online help, and search for External Data Structures.

Complete

N/A

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_AI_Location” data structure and review the default options available for the Location of A/I drop-down field in the data structure.

If changes are required in the default data structure options:

Change the default options in the data structure as desired, and click the Save button on the toolbar.

If changes are not required in the default data structure options:

Click the Cancel button on the toolbar, and then click the OK button on the confirmation message stating: “If you cancel, all changes will be lost. Do you wish to cancel?”

Complete

Default Custom

Bldg. A 3rd Floor West

Bldg. A 3rd Floor East

Bldg. B Ground Floor

Parking Lot

List items:

7

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_AI_IncidentType” data structure, and review the default options available for the Incident Type drop-down field in the data structure.


Change the default options in the data structure as desired, and click the Save button on the toolbar.


Click the Cancel button from the toolbar, and then click the OK button on the confirmation message stating: “If you cancel, all changes will be lost. Do you wish to cancel?”

Complete

Default Custom

Injury

Skin disorders

Respiratory condition

Poisoning

Hearing Loss

All Other Illnesses

List items:

Notes

8

5. Installation Items

Following is a list of records created by the installer.

InfoCard Types and Numbering Series

Template InfoCard Type: Quality

Template Numbering Series: SP Form – Imported (SP-FRM-xxxx)

Form InfoCard Types: Accident & Injury

Form Numbering Series: Accident & Injury Form (AIN-xxxx)

Vaults and Lifecycles

Template Vaults: Form Template Draft

Form Template Release

Form Template Archive

Template Lifecycle: Form Templates

Form Vaults: Accident & Injury Draft

Accident & Injury Release

Accident & Injury Archive

Aborted Forms

Form Lifecycle: Accident & Injury Forms

Roles

Roles: Safety Coordinator (SP_AIN_SafetyCoordinator)



Solution Package Sub-admins (SP_Subadmin)

Form Templates and Routes

Form Template: SP-FRM-0051

Route: Accident & Injury

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Data Structures

Data Structures: Departments

SP_CFG_AI_Location

SP_CFG_AI_IncidentType

SP_CFG_AI_Source

SP_TRANS_AIN

Template Mappings

The following template mappings are created by the installer associated with the Accident & Injury Solution Package. Refer to the Design Specification (SP-784) for the template mapping detail:

Accident&Injury-ExtRequest

EventCard Mappings

EventCard Mappings: (none)

Reports

Installer has created a default dataset named as SP-FRM-0051 and the following standard reports. Refer to the Design Specification (SP-784) for detailed report specifications.

Report Names: Active Accident/Injury Reports

Monthly Accident/Injury Reports by Department

Accident/Injury Reports by Sharp Type

OSHA Recordable Accident/Injury Reports by Month

Monthly Accident/Injury Reports By Incident Type

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6. Open Items

Record any open items in the space provided.

11

Action Item

12

Action Item Installation and Configuration Checklist

1. Overview: Action Item

This document is intended to guide users through the process of installing and/or configuring the MasterControl Action Item Solution.

IMPORTANT:

Any modification in excess of the configuration options presented in the checklists below is considered customization. Customization may require update of other documentation (such as the Operational Qualification, Functional Requirements Specification, Standard Operating Procedures, etc.).












13

Instruction Status




System Identified


Instruction Status




Action Item Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed

Click Save. It may take several minutes to complete the installations.

Installation complete



Complete

14

Instruction Status

Install the SP_QE_ActionItem_Menu.xml. This will create a quality event menu under a Quality Events main menu item for this solution.

IMPORTANT NOTE:


Menu(s) installed:


Install Test Users:

Go to Portal > Loading > Users to view a list of available users to install. Select the following users listed in the default column to install. It may take several seconds to complete the installation.


Go to Portal > User Management > Roles. Click the Edit icon next to each role, and in edit security role window, make sure that the test users have been associated with their appropriate roles as indicated in the Default column below .


Associate your own users to their appropriate roles and list them in the Custom column, below, next to the roles.

Enable the route:

Go to Process > Routes. In the Route Name column, locate Action Item.

In the Actions column of the Action Item row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Action Item Viewers (SP_HACT_ActionItemViewers )

HACT_USER1

HACT_USER2

HACT_USER3


Action Item Viewers (SP_HACT_ActionItemViewers )

___________________________

___________________________

___________________________


15

Instruction Status

SPSUBADMIN_User1

___________________________

___________________________

___________________________

The installed forms processes are now usable with default configuration options.

If configuration is required, then section 4.1, Post-Installation Configuration needs to be completed.



Notes


16

Instruction Status



SP-FRM- Rev


Complete

N/A

Notes


17

The following is a list of records created by the installer.




Form InfoCard Types: Action Items

Form Numbering Series: Action Item Form (AI-xxxx)






Form Vaults: Action Item Draft

Action Item Release

Action Item Archive

Aborted Forms

Form Lifecycle: Action Item Forms

Roles

Roles: Action Item Viewers (SP_HACT_ActionItemViewers )




Route: Action Item

18

Data Structures

Data Structures: SP_TRANS_AI

Template Mappings

Template Mappings: (none)

EventCard Mappings


Reports


Report Names: Action Items In Process

All Action Items

Action Items Past Due

19

6. Open Items


20

Audit Essentials

21

Audit Essentials Installation and Configuration Checklist

1. Overview: Audit Essentials

This document is intended to guide users through the process of installing and/or configuring the MasterControl Audit Essentials Solution.

IMPORTANT:








In such cases, the newly created records need to be manually reconciled with the existing configuration. Consult section 5 for a list of records the installer will place in the system.




22


Instruction Status




System Identified


Instruction Status




Audit Essentials Complete

Already installed

The following other form processes are included in this solution as required add-ons and need to be installed prior to use:

Action Item (see the “Action Item Installation and Configuration Checklist” section in this manual for installation detail)


Complete

Already installed

This solution package has optional capabilities for form-to-form launching of other MasterControl solution packages built in.

If MasterControl CAPA Essentials solution package is to be used, then select the following SP from the list:

CAPA Essentials

Complete

Already installed

Not Used


Complete

23

Instruction Status

If MasterControl CAPA Advanced solution package is to be used, then select the following SP from the list:

CAPA Advanced

Already installed

Not Used

This solution package has optional capabilities for form-to-form launching of other MasterControl solution packages.

If MasterControl Supplier Corrective Action (SCAR) solution package is to be used, then select the following SP from the list:

SCAR

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed





Items beginning with “SP_QE” will create solution-specific menus under a Quality Events main menu item. Items beginning with “SP_SA” will create standalone menus for the solution indicated.

It is recommended to install QE menus unless there are specific reasons to use standalone menus. If three or more MasterControl solutions are to be used, use of the SA menus is not recommended due to usability and space constraints on the menu bar.


IMPORTANT NOTE:

Complete

24

Instruction Status


Menu(s) installed:


Install Test Users:






Enable the routes:

Go to Process > Routes. In the Route Name column, locate both Audit Finding and Audit Summary.

In the Actions column of the Audit Finding and Audit Summary rows, click the Enable Route icons (green check mark) to enable the routes.

Blue checkmarks appears in the Status column of each row.

Complete

Default Custom

25

Instruction Status

Audit Coordinator (SP_AUD_Coordinator)

AUDIT_USER1

Lead Auditors (SP_AUD_LeadAuditors)

AUDIT_USER2

AUDIT_USER3

Auditors (SP_AUD_Auditors)

AUDIT_USER2

AUDIT_USER3

AUDIT_USER4

AUDIT_USER5

Audit Process Owners (SP_AUD_ProcessOwners)

AUDIT_USER6

AUDIT_USER7

Audit QA (SP_AUD_QA)

AUDIT_USER8

AUDIT_USER9

Extension Request Approvers (SP_AUD_ERApprovers)

AUDIT_USER10

AUDIT_USER11


SPSUBADMIN_User1

Audit Coordinator (SP_AUD_Coordinator)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

26

Instruction Status


If configuration is required, then sections 4.1 Post-Installation Configuration – Audit and 4.2 Post-Installation Configuration – Audit Finding, need to be completed.



Notes

4.1. Post-Installation Configuration – Audit

Instruction Status

Locate the template created by the installer (numbering series SP-FRM-xxxx). Check out the template InfoCard. The main file from this InfoCard is not needed.


SP-FRM- Rev

Complete

N/A

To dynamically populate a data structure’s drop-down options from an outside source, click the Edit Data Structure icon next to the data structure. Change the Data Structure from “Internal” to “External,” and fill out the relevant information. For more information on creating external data structures, consult the MasterControl online help, and search for External Data Structures.

Complete

N/A

27

Instruction Status

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_Audit_TargetQuarter” data structure, and review the default options available for the Target Quarter drop-down field in the data structure.


Change the default options in the data structure as desired, and click the Save button from the toolbar.



Complete

Default Custom

Q1

Q2

Q3

Q4

List items:

Click the Build Data Structure icon next to the “SP_CFG_Audit_TargetYear” data structure, and review the default options available for the Target Year drop-down field in the data structure.





Complete

28

Instruction Status

Default Custom

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

List items:

Click the Build Data Structure icon next to the “SP_CFG_Audit_Type” data structure, and review the default options available for the Type drop-down field in the data structure.



Note: Make sure the “Supplier" option remains unchanged in the default options of the “SP_CFG_Audit_Type” data structure during setup.



Complete

Default Custom

Internal

Supplier

Distributor/Partner

Regulatory/3rd Party

List items:

29

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_Audit_Category” data structure, and review the default options available for the Category drop-down field in the data structure.





Complete

Default Custom

Production and Process

Equipment and Facilities

Records

Documents and Change Control

Packaging and Labeling

Materials

Design and Development

Quality Control

Management

Finance

Sales and Marketing

List items:

Click the Build Data Structure icon next to the “SP_CFG_Audit_Department” data structure, and review the default options available for the Department drop-down field in the data structure.





Complete

30

Instruction Status

Default Custom

Administration

Engineering

Manufacturing

Marketing

Professional Services

Purchasing

Quality Control

Sales

List items:

Click the Build Data Structure icon next to the “SP_CFG_Audit_ProductLine” data structure, and review the default options available for the Product Line drop-down field in the data structure.





Complete

Default Custom

Product Line A

Product Line B

Product Line C

List items:

Click the Build Data Structure icon next to the “SP_CFG_Audit_Product” data structure, and review the default options available for the Product drop-down field in the data structure.





Complete

31

Instruction Status

Default Custom

Product 1

Product 2

Product 3

List items:

If the Audit form is to be configured for use with MasterControl Supplier (default):

No further configuration is necessary. In order to use the Audit form, Supplier InfoCards should be created in the system (MasterControl Supplier > Supplier InfoCard, Create InfoCards).

Complete

N/A

Click the Build Data Structure icon next to the “SP_CFG_Audit_Standard_Reference” data structure, and review the default options available for the Product drop-down field in the data structure.





Complete

Default Custom

ISO 13485

ISO 14971

ISO 14001

21 CFR 111

21 CFR 210

21 CFR 211

21 CFR 11

21 CFR 820

ICH Q9

ISO 9000

ISO 14000

Company SOP

Customer Requirements

OSHA

List Items:

32

Instruction Status

CAPA Type Selection

In the next three sections, select whether the CAPA form will be launched from Audit

If the CAPA Advanced (Issue Review) form is to be launched from Audit form (default):

CAPATYPE set to 1 represents CAPA Advanced (Issue Review) form launch

Open the Audit.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from Audit form:

CAPATYPE set to 2 represents CAPA Essentials form launch


Save the file.

Complete

N/A

If the CAPA Essentials form will *not* be launched from Audit form:

CAPATYPE set to 0 represents no CAPA form launch, and the reference field is editable


Save the file.

Complete

N/A

Supplier Corrective Action Type Selection

In the next two sections, select whether the SCAR form will be launched from Audit

If the SCAR form is to be launched from Audit (default):

SCARTYPE set to 1 represents SCAR form launch

Open the Audit.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 1 in the JS code.

Save the file.

Complete

N/A

33

Instruction Status

If the SCAR form will *not* be launched from Audit:

SCARTYPE set to 0 represents no SCAR form launch, and the reference field is editable

Open the Audit.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 0 in the JS code.

Save the file.

Complete

N/A

Check in the template InfoCard you previously checked out, and load the modified HTML file, and then click on the Form Fields tab.

Save the template, and quick approve it with an effective date of today. Mark the route available by clicking the “Make Route Available” icon next to the route, and the solution package is ready for use.

Complete

Notes

34

4.2. Post-Installation Configuration – Audit Finding

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Click the Build Data Structure icon next to the “SP_CFG_Audit_Standard_Reference” data structure, and review the default options available for the Product drop-down field in the data structure.





Complete

Default Custom

ISO 9000

ISO 13485

ISO 14971

ISO 14001

21 CFR 111

21 CFR 210

21 CFR 211

21 CFR 11

21 CFR 820

ICH Q9

ISO 14000

Company SOP

Customer Requirements

OSHA

Describe datasource or list static items:

35

Instruction Status

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_AuditFinding_Category” data structure, and review the default options available for the Category drop-down field in the data structure.





Complete

Default Custom

Environment

Equipment

Materials

Methods

Personnel

Plant

List items:

CAPA Type Selection

In the next two sections, select whether the CAPA form will be launched from Audit Finding

If the CAPA Advanced (Issue Review) form is to be launched from Audit Finding form (default):

CAPATYPE set to 1 represents CAPA Advanced (Issue Review) form launch

Open the Audit_Finding.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from Audit Finding form:

CAPATYPE set to 2 represents CAPA Essentials form launch

Open the Audit_Finding.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 2 in the JS code.

Save the file.

Complete

N/A

Supplier Corrective Action Type Selection

36

Instruction Status

In the next two sections, select whether the SCAR form will be launched from Audit

If the SCAR form is to be launched from Audit (default):

SCARTYPE set to 1 represents SCAR form launch

Open the Audit_Finding.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 1 in the JS code.

Save the file.

Complete

N/A

If the SCAR form will *not* be launched from Audit:

SCARTYPE set to 0 represents no SCAR form launch, and the reference field is editable

Open the Audit_Finding.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 0 in the JS code.

Save the file.

Complete

N/A

Check in the template InfoCard that you previously checked out, and load the modified HTML file, and then click on the Form Fields tab.

Save the template, and quick approve it with an effective date of today.

Mark the route available by clicking the “Make Route Available” icon next to the route, and the solution package is ready for use.

Complete

Notes

37

Instruction Status

38






Form InfoCard Types: Audit

Audit Finding

Form Numbering Series: Audit Form (Audit-xxxx)

Audit Finding Form (Finding-xxxx)






Form Vaults: Audit Inprocess

Audit Complete

Audit Archive

Audit Finding Inprocess

Audit Finding Complete

Audit Finding Archive

Aborted Forms

Form Lifecycles: Audit Forms

Audit Finding Forms

39


Roles

Roles: Audit Coordinator (SP_AUD_Coordinator)







40


Form Templates: SP-FRM-0044

SP-FRM-0045

Routes: Audit Summary

Audit Finding

Data Structures

Data Structures: SP_CFG_Audit_TargetQuarter

SP_CFG_Audit_TargetYear

SP_CFG_Audit_Type

SP_CFG_Audit_Department

SP_CFG_Audit_Category

SP_CFG_Audit_ProductLine

SP_CFG_Audit_Product

SP_CFG_Audit_Source

SP_CFG_AuditFinding_Category

SP_CFG_AuditFinding_Source

SP_TRANS_AUD

SP_TRANS_AUD_FIND

Template Mappings

41

The following template mappings are created by the installer associated with the Audit Essentials Solution Package. Refer to the Design Specification (SP-786) for the template mapping detail:

Audit-ActionItem

Audit-AuditFind

Audit-CAPA

Audit-ExtRequest

Audit-IssueReview

Audit-SCAR

AuditFind-ActionItem

AuditFind-CAPA

AuditFind-ExtRequest

AuditFind-IssueReview

AuditFind-SCAR

EventCard Mappings

If EventCards are licensed:

The following EventCard mapping is created by the installer associated with the Audit Essentials Solution Package. Refer to the Design Specification (SP-786) for the EventCard mapping detail:

Audit_Agent

AuditFinding_Agent

AuditFinding_Event

Reports

Installer has created the default datasets named as SP-FRM-0044 and SP-FRM-0045 and the following standard reports. Refer to the Design Specification (SP-786) for detailed report specifications.

Report Names: Audit by Lead Auditor

Audit by Month

Audit by Department

Audit Finding Summary

Audit Findings In Process

Audit Finding by Category

42

6. Open Items


43

CAPA Advanced

44

CAPA Advanced Installation and Configuration Checklist

1. Overview: CAPA Advanced

This document is intended to guide through the process of installing and/or configuring the MasterControl CAPA Advanced Solution.

IMPORTANT:








In such cases, the newly created records need to be manually reconciled with the existing configuration. Consult the Installation Items section for a list of records the installer will place in the system.




45


Instruction Status

Verify that the installation environment is MasterControl Portal version 11.0.x or higher.



System Identified


Instruction Status




CAPA Advanced

Complete

Already installed




Complete

Already installed


If MasterControl Change Control Advanced solution package is to be used, then select the following SP from the list:

Change Control Advanced

Complete

Already installed

Not Used

46

Instruction Status


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Menu(s) installed:

Complete

47

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate CAPA Adv and Issue Review Adv.

In the Actions column of the CAPA Adv and Issue Review Adv rows, click the Enable Route icon (green check mark) to enable the route.

A blue checkmark appears in the Status column of each row.

Complete

Default Custom

CAPA Manager (SP_CAPA_Manager)

HCAPA_USER1

CAPA Participants (SP_CAPA_Participants)

HCAPA_USER2

HCAPA_USER3

CAPA Approvers (SP_CAPA_Approvers)

HCAPA_USER4

HCAPA_USER5

QA CAPA (SP_CAPA_QA)

HCAPA_USER6

HCAPA_USER7

CAPA Manager (SP_CAPA_Manager)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

48

Instruction Status

CAPA Owners (SP_CAPA_Owners)

HCAPA_USER8

HCAPA_USER9

HCAPA_USER10

Extension Request Approvers (SP_CAPA_ExtReqApprovers)

HCAPA_USER11

HCAPA_USER12


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


If configuration is required, then sections Post-Installation Configuration – Issue Review and Post-Installation Configuration – CAPA need to be

completed.



Notes

49

Instruction Status

4.1. Post-Installation Configuration – Issue Review

Instruction Status



SP-FRM- Rev


Complete

N/A

MasterControl can optionally be configured to allow users to launch an Issue Review form from a MasterControl Audit workspace. To enable this feature you simply have to create a data mapping from Audit to the form. The mapping will push the data from the Audit to the form when a user initiates the form launch.

The Issue Review form has two fields on the About tab that tell a user where it was initiated from, the Source (a categorization, such as Audit, Audit Finding, or Supplier Audit) and the Other Source (a reference field, in this scenario typically the Audit Number). At the minimum these two fields should receive data from the Audit through this data mapping.

If users should be able to launch an Issue Review form from the audit workspace in MasterControl Audit:

Navigate to Process > Templates > Template Mapping and ensure that there is a mapping between MasterControl Audit (Parent) and SP-FRM-0031 (Child).

Audit Field Issue Review Field

T1 Source

T1 Other Source

The second mapping will only successfully pass if one of the drop-downs on the “T1 Source” field matches the data being passed in. Therefore, make sure to add all possible data strings to the “SP_CFG_CAPA_Adv_Source” data structure (see below).

Record any other mappings here:

Complete

N/A

50

Instruction Status


Complete

N/A

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_CAPA_Adv_Source” data structure, and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Audit

Audit Finding

Customer Complaint

Deviation

Finished Goods Inspection

Incoming Goods Inspection

Incident Report

MDR

Nonconformance

Out of Specification

Process Deviation

Product Nonconformance

Re-Occurring Problem

Trend Analysis

Other

List items:

51

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CAPA_Adv_FailureCode” data structure, and review the default options available for the Failure Code drop-down field in the data structure.





Complete

Default Custom

Failure Code 1

Failure Code 2

Failure Code 3

Failure Code 4

Failure Code 5

List items:

Notes

52

4.2. Post-Installation Configuration – CAPA

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Change Control Mode Selection (MC, None, or Other):

If the Change Control is to be used (default):

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

Save the file.

If no Change Control system will be used:

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

Save the file.

If no Change Control system will be used, and the reference field is editable:

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

Save the file.

Complete

53

Instruction Status

Advanced Packet Mode Selection (MC or None):

If MasterControl Advanced Packet is to be used (default):

Open CAPA.html file in any HTML editor, and search the section var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “MC” in the JS code.

Save the file.

If no Advanced Packet will be used:

Open CAPA.html file in any HTML editor, and search the section var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “None” in the JS code.

Save the file.

Complete

Check in the template InfoCard you previously checked out, and load the modified CAPA HTML file as the template’s main file, and then click on the Form Fields tab.



Complete

54

Instruction Status

Notes

55






Form InfoCard Types: CAPA

Issue Review

Form Numbering Series: Issue Review Form (Issue-xxxx)

CAPA Form (CAPA-xxxx)






Form Vaults: Issue Review Draft

Issue Review Release

Issue Review Archive

CAPA Inprocess

CAPA Release

CAPA Archive

Aborted Forms

Form Lifecycles: Issue Review Forms

CAPA Forms

56

Roles

Roles: CAPA Manager (SP_CAPA_Manager)









SP-FRM-0032

Routes: Issue Review Adv

CAPA Adv

Data Structures

Data Structures: Products

SP_CFG_CAPA_Adv_Source

SP_CFG_CAPA_Adv_FailureCode

SP_TRANS_HCAPA

SP_TRANS_ISSUE

Template Mappings

57

The following template mappings are created by the installer associated with the CAPA Advanced Solution Package. Refer to the Design Specification (SP-787) for the template mapping detail:

IssueReview-CAPA

IssueReview-ActionItem

IssueReview-ExtensionRequest

CAPAAdv-ChangeControlAdv

CAPAAdv-ActionItem

CAPAAdv-ExtensionRequest

EventCard Mappings


The following EventCard mapping is created by the installer associated with the CAPA Advanced Solution Package. Refer to the Design Specification (SP-787) for the EventCard mapping detail:

CAPAAdv_Agent

CAPAAdv_Event

Agent_IssueReviewAdv

IssueReviewAdv_Agent

IssueReviewAdv_Event

Reports

Installer has created default datasets named as SP-FRM-0031 and SP-FRM-0032, and the following standard reports. Refer to the Design Specification (SP-787) for detailed report specifications.

Issue Review Form - Report Names: Issue Reviews In Process

Issue Reviews By Source

Issue Reviews By Score

CAPA Form - Report Names: CAPA In Process

CAPA by Source

CAPA 12-Month Trend

58

6. Open Items


59

CAPA Essentials

60

CAPA Essentials Installation and Configuration Checklist

1. Overview: CAPA Essentials

This document is intended to guide users through the process of installing and/or configuring the MasterControl CAPA Essentials Solution.

IMPORTANT:












61


Instruction Status




System Identified


Instruction Status




CAPA Essentials Complete

Already installed




Complete

Already installed




Complete

Already installed

Not Used


Template Mappings

Complete

62

Instruction Status


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Menu(s) installed:

Complete

63

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate CAPA.

In the Actions column of the CAPA row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

CAPA Coordinator (SP_CAPA_Coordinator)

CAPA_USER1

CAPA Users (SP_CAPA_Users)

CAPA_USER2

CAPA_USER3

CAPA_USER4

CAPA_USER5

Task Owners (SP_CAPA_TaskOwners)

CAPA_USER6

CAPA_USER7

CAPA Coordinator (SP_CAPA_Coordinator)

______________________________

______________________________


______________________________

______________________________

______________________________

_____________________________


______________________________

______________________________

______________________________

64

Instruction Status

Process Owners (SP_CAPA_ProcessOwners)

CAPA_USER8

CAPA_USER9

Extension Request Approvers (SP_CAPA_ERApprovers)

CAPA_USER10

CAPA_USER11


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


The default configuration includes:

- For fields with multiple possible data sources, the default form will be configured to use data structures from MasterControl Data or use of external data structures will require further configuration.




Notes

65


Instruction Status



SP-FRM- Rev

Complete

N/A

MasterControl can optionally be configured to allow users to launch CAPA form from a MasterControl Audit workspace. To enable this feature you simply have to create a data mapping from Audit to the form. The mapping will push the data from the Audit to the form when a user initiates the form launch.

The CAPA form has two fields on the About tab that tell a user where it was initiated from, the Source (a categorization, such as Audit, Audit Finding, or Supplier Audit) and the Other Source (a reference field, in this scenario typically the Audit Number). At the minimum these two fields should receive data from the Audit through this data mapping.

If users should be able to launch a CAPA Essentials form from the audit workspace in MasterControl Audit:

Navigate to Process > Templates > Template Mapping and ensure that there is a mapping between MasterControl Audit (Parent) and SP-FRM-0039 (Child).

Audit Field CAPA Field

T1 Source

T1 Other Source

The second mapping will only successfully pass if one of the drop-downs on the “T1 Source” field matches the data being passed in. Therefore, make sure to add all possible data strings to the “SP_CFG_CAPA_Source” data structure (see below).

Record any other mappings here:

Complete

N/A


Complete

N/A

66

Instruction Status

If MasterControl Data structure (MCD) was selected as the desired source for the Product Info while setting the configuration variable for it, then skip this step.

To populate the Affected Product drop-down options dynamically from an outside source, create the following external data structures:

1. Datasource Name: Product Info

SELECT db_product_description AS "Product_Description" FROM

db_tablename WHERE db_product = '[value]'

Substitute in the SQL statement appropriate field names for db_product, db_product_description; substitute appropriate table name for db_tablename;

2. Datasource Name: Products

SELECT db_product FROM db_tablename

Substitute in the SQL statement the appropriate field name for db_product; substitute the appropriate table name for db_tablename;

For more information on creating external data structures, consult the appropriate MasterControl manuals.

Describe Data Structure Items:

Complete

N/A

67

Instruction Status

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_CAPA_Source” data structure, and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Analyzer Agent

Trend Analysis

Incoming Goods Inspection

Finished Goods Inspection

Audit

Audit Finding

Customer Complaint

Deviation

Incident Report

Nonconformance

Out-of-Specification

Supplier Deviation

Variance

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CAPA_Failure_Code” data structure, and review the default options available for the Failure Code drop-down field in the data structure.





Complete

68

Instruction Status

Default Custom

Code 1

Code 2

Code 3

List items:


If MasterControl Change Control is to be used (default):

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

Save the file.

If no Change Control system will be used:

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

Save the file.


Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

Save the file.

Complete


If MasterControl Advanced Packet is to be used (default):

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLADVPACKET. Make sure the CHANGECONTROLADVPACKET variable is set to “MC” in the JS code.

Save the file.

If no Advanced Packet will be used:

Open the CAPA.html file in any HTML editor, and search for var CHANGECONTROLADVPACKET. Make sure the CHANGECONTROLADVPACKET variable is set to “None” in the JS code.

Save the file.

Complete

Check in the template InfoCard that you previously checked out, and load the modified HTML file, and then click on the Form Fields tab.

Save the template and quick approve it with an effective date of today.


Complete

69

Instruction Status

Notes

70






Form InfoCard Types: CAPA

Form Numbering Series: CAPA Form (CAPA-xxxx)






Form Vaults: CAPA Inprocess

CAPA Release

CAPA Archive

Aborted Forms

Form Lifecycle: CAPA Forms

Roles

Roles: CAPA Coordinator (SP_CAPA_Coordinator)








Route: CAPA

71

Data Structures


Products

SP_CFG_CAPA_Source

SP_CFG_CAPA_Failure_Code

SP_TRANS_CAPA

Template Mappings

The following template mappings are created by the installer associated with the CAPA Essentials Solution Package. Refer to the Design Specification (SP-788) for the template mapping detail:

CAPA-ChangeControlAdv

CAPA-ActionItem

CAPA-ExtRequest

EventCard Mappings


The following EventCard mapping is created by the installer associated with the CAPA Essentials Solution Package. Refer to the Design Specification (SP-788) for the EventCard mapping detail:

CAPA_Agent

CAPA_Event

Agent_CAPA

Reports


Report Names: CAPA Summary

CAPA Overdue

CAPA by Department

CAPA by Step

CAPA by Month

CAPA by Product

72

6. Open Items


73


74

Change Control Advanced Installation and Configuration Checklist

1. Overview: Change Control Advanced

This document is intended to guide users through the process of installing and/or configuring the MasterControl Change Control Advanced Solution.

IMPORTANT:












75


Instruction Status




System Identified


Instruction Status




Change Control Advanced Complete

Already installed




Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed

Click Save. It may take several minutes to complete the installations. Installation complete

76

Instruction Status






IMPORTANT NOTE:


Menu(s) installed:

Complete

77

Instruction Status


Install Test Users:






Enable the routes:

Go to Process > Routes. In the Route Name column, locate Change Control Advanced.

In the Actions column of the Change Control Advanced row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

CR Managers (SP_CR_Managers)

CR_USER1

CR Users (SP_CR_Users)

CR_USER2

CR_USER3

CR Validation (SP_CR_Validation)

CR_USER4

CR_USER5

CR Training (SP_CR_Training)

CR_USER6

CR_USER7

CR Managers (SP_CR_Managers)

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

78

Instruction Status

CR Regulatory (SP_CR_Regulatory)

CR_USER8

CR_USER9

Extension Request Approvers (SP_CR_ExtReqApprovers)

CR_USER10

CR_USER11


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


If configuration is required, then section 4.1, Post-Installation Configuration, needs to be completed.



Notes

79


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Affected Items Mode Selection (ENABLE or DISABLE):

If you wish to enabled the Affected Items control on the Change Control Advanced form (default):

Open Change_Control_Advanced.html file in any HTML editor, and search for var AFFECTED_COMP. Make sure the AFFECTED_COMP variable is set to ENABLE in the JS code.

Save the file.

If you wish to disabled the Affected Items control on the Change Control Advanced form:

Open Change_Control_Advanced.html file in any HTML editor, and search for var AFFECTED_COMP. Make sure the AFFECTED_COMP variable is set to DISABLE in the JS code.

Save the file.

Complete

Changed Items Mode Selection (ENABLE or DISABLE):

If you wish to enabled the Changed Items control on the Change Control Advanced form (default):

Open Change_Control_Advanced.html file in any HTML editor and search the section var CHANGED_COMP from code. And make sure the CHANGED_COMP variable is set to ENABLE in the JS code.

Save the file.

If you wish to disabled the Changed Items control on the Change Control Advanced form:

Open Change_Control_Advanced.html file in any HTML editor and search the section var CHANGED_COMP from code. And make sure the CHANGED_COMP variable is set to DISABLE in the JS code.

Save the file.

Complete

80

Instruction Status

Adv Packet Mode Selection (DISABLE, USER SELECTED PACKET, or STATIC PACKET)

Launching an Advanced Packet/Document Change Request from the Change Control Advanced form.

If Document Change Request (Advanced Packet) will *not* be used:

Open the Change_Control_Advanced.html file in any HTML editor, and search for var ADVPACKET. Make sure the ADVPACKET variable is set to DISABLE in the JS code.

Save the file.

If Document Change Request (Advanced Packet) will be used with a Packet Type List available (default):

Open the Change_Control_Advanced.html file in any HTML editor, and search for var ADVPACKET. Make sure the ADVPACKET variable is set to USER SELECTED PACKET in the JS code.

Save the file.

If Document Change Request (Advanced Packet) will be used without a Packet Type List:

Open the Change_Control_Advanced.html file in any HTML editor, and search for var ADVPACKET. Make sure the ADVPACKET variable is set to STATIC PACKET in the JS code.

Save the file.

Click the Build Data Structure icon next to the “Products” data structure, and review the default options available for the Product drop-down field in the data structure.





Complete

Default Custom

(blank)

Product A

Product B

Product C

Describe Datasource Items:

81

Instruction Status

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures. Click the Build Data Structure icon next to the “SP_CFG_ChangeControl_Adv_TypeofChange” data structure, and review the default options available for the Type of Change drop-down field in the data structure.





Complete

Default Custom

Components or Composition

Design

Manufacturing Process

Facility/Equipment

Packaging

Labeling

Documentation

List items:

Click the Build Data Structure icon next to the “SP_CFG_ChangeControl_Adv_Source” data structure, and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Audit Finding

CAPA

Customer Complaint

Deviation

List items:

82

Instruction Status

Supplier Deviation

Variance

Other

Notes

83

Instruction Status

84






Form InfoCard Types: Change Control Advanced

Form Numbering Series: Change Control Advanced Form (CR-xxxx)






Form Vaults: Change Control Advanced Draft

Change Control Advanced Release

Change Control Advanced Archive

Aborted Forms

Form Lifecycle: Change Control Advanced Forms

Roles

Roles: CR Managers (SP_CR_Managers)









Route: Change Control Advanced

85

86

Data Structures


SP_CFG_ChangeControl_Adv_TypeofChange

SP_CFG_ChangeControl_Adv_Source

SP_TRANS_CCAdv

Template Mappings

The following template mappings are created by the installer associated with the Change Control Advanced Solution Package. Refer to the Design Specification (SP-789) for the template mapping detail:

ChangeControlAdv-ActionItem

ChangeControlAdv-Ext Request

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Change Control Advanced Solution Package. Refer to the Design Specification (SP-789) for the EventCard mapping detail:

ChangeControlAdv_Event

Reports


Report Names: CRs In Process

CRs Completed

CRs Past Due

87

6. Open Items


88

Clinical CAPA

89

Clinical CAPA Installation and Configuration Checklist

1. Overview: Clinical CAPA

This document is intended to guide users through the process of installing and/or configuring the MasterControl Clinical CAPA Solution.

IMPORTANT:







The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes, and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with “_LOAD”

In such cases, the newly created records need to be manually reconciled with the existing

configuration. Consult the Installation Items section for a list of records the installer will

place in the system.




90


Instruction Status




System Identified


Instruction Status




Clinical CAPA

Complete

Already installed




Complete

Already installed




Complete

Already installed

Not Used

91

Instruction Status


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_CT_Clinical_CAPA_Menu.xml. This will create a Clinical Trials menu for this solution.


IMPORTANT NOTE:


Menu(s) installed:

Complete

92

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Clinical CAPA.

In the Actions column of the Clinical CAPA row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Clinical Research Assistant (SP_CTCAPA_ClnRsrchAsstnt)

CTCAPA_USER1

Clinical Site Monitor (SP_CTCAPA_ClinicSiteMon)

CTCAPA_USER1

CTCAPA_USER2

Study Director (SP_CTCAPA_StudyDirector)

CTCAPA_USER3

CTCAPA_USER4

Clinical QA Approver (SP_CTCAPA_QA_Approver) CTCAPA_USER6

CTCAPA_USER7

Clinical Research Assistant (SP_CTCAPA_ClnRsrchAsstnt)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

Clinical QA Approver (SP_CTCAPA_QA_Approver)

______________________________

93

Instruction Status

Extension Request Approvers (SP_CTCAPA_ERApprovers)

CTCAPA_USER5


SPSUBADMIN_User1

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


If configuration is required, then the Post-Installation Configuration section needs to be

completed.



Notes

94


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A


If the MasterControl Change Control is to be used (default): - Open the Clinical_CAPA.html file in any HTML editor, and search for var

CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

- Save the file.

If no Change Control system will be used: - Open the Clinical_CAPA.html file in any HTML editor, and search for var

CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

- Save the file.

If no Change Control system will be used, and the reference field is editable: - Open the Clinical_CAPA.html file in any HTML editor, and search for var

CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

Go to Portal > Data Structures > Data Structures to view a list of available MasterControl data structures.

Click the Build Data Structure icon next to the “SP_CFG_CT_DosageForm” data structure and review the default options available for the Dosage and Dosage Form drop-down field in the data structure.


Change the default options in the data structure as desired and click the Save button from the toolbar.


Click the Cancel button from the toolbar and then click the OK button on the confirmation message stating: “If you cancel, all changes will be lost. Do you wish to cancel?”

Complete

95

Instruction Status

Default Custom

Dosage Form 1

Dosage Form 2

Dosage Form 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_StudyNumber” data structure and review the default options available for the Study Number drop-down field in the data structure.




Click the Cancel button from the toolbar and then click the OK button on the confirmation message stating: “If you cancel, all changes will be lost. Do you wish to cancel?” Complete

Default Custom

Study 1

Study 2

Study 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_Sponsor” data structure and review the default options available for the Sponsor/CRO drop-down field in the data structure.





Complete

Default Custom

96

Instruction Status

Sponsor 1

Sponsor 2

Sponsor 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_IssueArea” data structure and review the default options available for the Issue Area drop-down field in the data structure.





Complete

Default Custom

Patient Enrolment (unqualified)

Patient Enrolment (low/dropout/withdraw)

Patient Enrolment (other)

Documentation (incomplete)

Documentation (other)

Support Staff (unqualified)

Support Staff (training)

Support Staff (other)

Patient Safety (high number of SAEs)

Investigational Product (storage)

Investigational Product (expired)

Investigational Product (missing)

Investigational Product (other)

Data Collection (incomplete)

Data Collection (inaccurate)

Data Collection (other)

List items:

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

97

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_ClinicalCAPA_Source” data structure, and review the default options available for the Source drop-down field in the data structure.





Default Custom

Site Qualification Visit/Call

Initiation Monitoring Visit/Call

Interim Monitoring Visit/Call

Closeout Monitoring Visit/Call

Data and Safety Monitoring Visit/Call

Data and Efficacy Monitoring Visit/Call

Clinical Site Audit

Clinical Issue/Deviation

Other (specify in other)

List items:

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

_________________________________

98

Check in the template InfoCard you previously checked out, and load the modified HTML file as the template’s main file, and then click on the Form Fields tab.



Complete

Notes

99




Template InfoCard Type: Clinical Trials


Form InfoCard Types: Clinical CAPA

Form Numbering Series: Clinical CAPA Form (ClinCAPA-xxxxx)






Form Vaults: Clinical CAPA Draft

Clinical CAPA Release

Clinical CAPA Archive

Aborted Forms

Form Lifecycle: Clinical CAPA Forms

Roles

Roles: Clinical Research Assistant (SP_CTCAPA_ClnRsrchAsstnt)



Clinical QA Approver (SP_CTCAPA_QA_Approver)





Route: Clinical CAPA

100

Data Structures


SP_CFG_ClinicalCAPA_Source

SP_CFG_CT_DosageForm

SP_CFG_CT_StudyNumber

SP_CFG_CT_Sponsor

SP_CFG_CT_IssueArea

SP_TRANS_CCAPA

Template Mappings

The following template mappings are created by the installer associated with the Clinical CAPA Solution Package. Refer to the Design Specification (SP-790) for the template mapping detail:

ClinicalCAPA-ActionItem

ClinicalCAPA-ExtensionRequest

ClinicalCAPA-ChangeControlAdv

EventCard Mappings


Reports


Report Names: Clinical CAPA In Process

Clinical CAPA by Source

Clinical CAPA 12-Month Trend

101

6. Open Items


102

Clinical Deviation

103

Clinical Deviation Installation and Configuration Checklist

1. Overview: Clinical Deviation

This document is intended to guide users through the process of installing and/or configuring the MasterControl Clinical Deviation Solution.

IMPORTANT:







The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with “_LOAD”







104


Instruction Status




System Identified


Instruction Status




Clinical Deviation

Complete

Already installed




Complete

Already installed


If MasterControl Clinical CAPA solution package is to be used, then select the following SP from the list:

Clinical CAPA

Complete

Already installed

Not Used

105

Instruction Status


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_CT_Clinical_Deviation_Menu. This will create a Clinical Trials menu for this solution.


IMPORTANT NOTE:

You may receive an error notification that states that a dataset specified in the menu does not exist in your target system. Creation of the dataset is triggered by the previous installation step and may take up to 30 minutes to complete, depending on server load and the number of solutions being installed. If you encounter this error, please try again after an adequate amount of time.

Menu(s) installed:

Complete

106

Instruction Status


Install Test Users:

Go to Portal > Loading > Users to view a list of available users to install. To choose which users to install, refer to the Default Column below. Select those users on the Loading > Users window in MasterControl. It may take several seconds to complete the installation.


Go to Portal > User Management > Roles then click the Edit icon next to each role and in edit security role window make sure that the test users have been associated with their appropriate roles as indicated below in the Default column.



Enable the route:

Go to Process > Routes. In the Route Name column, locate Clinical Deviation.

In the Actions column of the Clinical Deviation row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Clinical Research Assistant (SP_CTDEV_ClnRsrchAsstnt)

CTDEV_USER1

Clinical Site Monitor (SP_CTDEV_ClinicSiteMon)

CTDEV_USER1

CTDEV_USER2

Extension Request Approvers (SP_CTDEV_ERApprovers)

CTDEV_USER3

Clinical Research Assistant (SP_CTDEV_ClnRsrchAsstnt)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

107

Instruction Status


SPSUBADMIN_User1


___________________________

___________________________

___________________________


If configuration is required, then the Post-Installation Configuration section

needs to be completed.



Notes


Instruction Status



SP-FRM- Rev


Complete

N/A


Complete

N/A

108

Instruction Status

If the Clinical CAPA form is to be launched from Clinical Deviation form (default):

CAPA Mode Selection (when CAPAMODE is set to ‘MC' - which represents Clinical CAPA form launch):

- Open the Clinical_Deviation.html file in any HTML editor, and search for var CAPAMODE. Make sure the CAPAMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

If the Clinical CAPA form will *not* be launched from Clinical Deviation form:

CAPA Mode Selection (when CAPAMODE is set to ‘Other’ - which represents no CAPA form launch, and the reference field is editable):

- Open the Clinical_Deviation.html file in any HTML editor, and search for var CAPAMODE. Make sure the CAPAMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_CT_ClinicalDeviationSource” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Site Qualification Visit/Call

Initiation Monitoring Visit/Call

Interim Monitoring Visit/Call

Closeout Monitoring Visit/Call

Data and Safety Monitoring Visit/Call

Data and Efficacy Monitoring Visit/Call

Clinical Site Audit

Other (specify in other)

List items:

109

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CT_DosageForm” data structure and review the default options available for the Dosage and Dosage/Form drop-down field in the data structure.





Complete

Default Custom

Dosage Form 1

Dosage Form 2

Dosage Form 3

List items:






Complete

Default Custom

Study 1

Study 2

Study 3

List items:

110

Click the Build Data Structure icon next to the “SP_CFG_CT_Sponsor” data structure and review the default options available for the Sponsor drop-down field in the data structure.





Complete

Default Custom

Sponsor 1

Sponsor 2

Sponsor 3

List items:

111

Click the Build Data Structure icon next to the “SP_CFG_CT_IssueArea” data structure and review the default options available for the Issue Area drop-down field in the data structure.





Complete

Default Custom

Patient Enrolment (unqualified)

Patient Enrolment (low/dropout/withdraw)

Patient Enrolment (other)

Documentation (incomplete)

Documentation (other)

Support Staff (unqualified)

Support Staff (training)

Support Staff (other)

Patient Safety (high number of SAEs)

Investigational Product (storage)

Investigational Product (expired)

Investigational Product (missing)

Investigational Product (other)

Data Collection (incomplete)

Data Collection (inaccurate)

Data Collection (other)

List items:

112

Click the Build Data Structure icon next to the “SP_CFG_CT_Department” data structure and review the default options available for the Department drop-down field in the data structure.





Complete

Default Custom

Biometrics

Clinical

Commercial Compliance

Information Technology

Legal

Medical Affairs

Pharmaceutical Operations

Preclinical

Quality Assurance

Regulatory

List items:

113

Notes

114






Form InfoCard Types: Clinical Deviation

Form Numbering Series: Clinical Deviation Form (CDev-xxxxx)






Form Vaults: Clinical Deviation Draft

Clinical Deviation Release

Clinical Deviation Archive

Aborted Forms

Form Lifecycle: Clinical Deviation Forms

Roles

Roles: Clinical Research Assistant (SP_CTDEV_ClnRsrchAsstnt)






Route: Clinical Deviation

115

Data Structures


SP_CFG_CT_ClinicalDeviationSource

SP_CFG_CT_Department



SP_CFG_CT_Sponsor

SP_CFG_CT_IssueArea

SP_TRANS_CDEV

Template Mappings

The following template mappings are created by the installer associated with the Clinical Deviation Solution Package. Refer to the Design Specification (SP-791) for the template mapping detail:

ClinicalDeviation-ActionItem

ClinicalDeviation-ExtRequest

ClinicalDeviation-ClinicalCAPA

EventCard Mappings


Reports


Report Names: Issues Detail

Issues In-Process

Issues by Product

Issues by Study Number

116

6. Open Items


117

Clinical Site Closeout

118

Clinical Site Closeout Installation and Configuration Checklist

1. Overview: Clinical Site Closeout

This document is intended to guide users through the process of installing and/or configuring the MasterControl Clinical Site Closeout Solution.

IMPORTANT:







The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with “_LOAD.”





- First, ALWAYS install the solution package in a test environment that mirrors the production system. This allows system administrators to work out the procedure for updating the production system, minimizing the impact to existing data and records.


119


Instruction Status




System Identified


Instruction Status





Complete

Already installed




Complete

Already installed


If MasterControl Clinical Deviation solution package is to be used, then select the following SP from the list:

Clinical Deviation

Complete

Already installed

Not Used


Template Mappings

Complete

120

Instruction Status


Data Structures

Complete

Already installed





Install the SP_CT_Clinical_Site_Closeout_Menu.xml. This will create a Clinical Trials menu for this solution.


IMPORTANT NOTE:


Menu(s) installed:

Complete


Install Test Users:



Complete

121

Instruction Status




Enable the route:

Go to Process > Routes. In the Route Name column, locate Clinical Site Closeout.

In the Actions column of the Clinical Site Closeout row, click the Enable Route icon (green check mark) to enable the route.


Default Custom

Clinical Research Assistant (SP_CTSCLO_ClnRsrchAsstnt)

CTSCLO_USER1

Clinical Site Monitor (SP_CTSCLO_ClinicSiteMon)

CTSCLO_USER1

CTSCLO_USER2

Study Director (SP_CTSCLO_StudyDirector)

CTSCLO_USER3

CTSCLO_USER4

Owner (SP_CTSCLO_Owners)

CTSCLO_USER6

Clinical Research Assistant (SP_CTSCLO_ClnRsrchAsstnt)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

Owner (SP_CTSCLO_Owners)

______________________________

______________________________

______________________________

122

Instruction Status

Extension Request Approvers (SP_CTSCLO_ERApprovers)

CTSCLO_USER5


SPSUBADMIN_User1


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________






Notes


Instruction Status



SP-FRM- Rev

Complete

N/A

123

Instruction Status


Complete

N/A

If the Clinical Deviation form is to be launched from Clinical Site Closeout form (default):

Deviation Mode Selection (when DEVIATIONMODE is set to ‘MC' - which represents Clinical Site Deviation form launch):

- Open the Clinical_Site_Closeout.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Deviation form will *not* be launched from Clinical Site Closeout form:

Deviation Mode Selection (when DEVIATIONMODE is set to ‘Other’ - which represents no Clinical Site Deviation form launch, and the reference field is editable):

- Open the Clinical_Site_Closeout.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_CT_DosageForm” data structure and review the default options available for the Dosage/Form drop-down field in the data structure.





Complete

Default Custom

Dosage Form 1

Dosage Form 2

Dosage Form 3

List items:

124

Instruction Status






Complete

Default Custom

Study 1

Study 2

Study 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_RoleInStudy” data structure and review the default options available for the RoleInStudy drop-down field in the data structure.





Complete

Default Custom

Principal Investigator

Sub-Investigator

Study Nurse

Study Coordinator

Other

List items:

125

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CT_Indication” data structure and review the default options available for the Indication drop-down field in the data structure.





Complete

Default Custom

Indication 1

Indication 2

Indication 3

List items:

Notes

126






Form InfoCard Types: Clinical Site Closeout

Form Numbering Series: Clinical Site Closeout Form (CSClose-xxxxx)






Form Vaults: Clinical Site Closeout Draft

Clinical Site Closeout Release

Clinical Site Closeout Archive

Aborted Forms

Form Lifecycle: Clinical Site Closeout Forms

Roles

Roles: Clinical Research Assistant (SP_CTSCLO_ClnRsrchAsstnt)




Owners (SP_CTSCLO_Owners)




Route: Clinical Site Closeout

127

Data Structures




SP_CFG_CT_Indication

SP_CFG_CT_RoleInStudy

SP_TRANS_CCLOSEOUT

Template Mappings

The following template mappings are created by the installer associated with the Clinical Site Closeout Solution Package. Refer to the Design Specification (SP-792) for the template mapping detail:

SiteCloseout-ActionItem

SiteCloseout-ExtRequest

SiteCloseout-ClinicalDeviation

EventCard Mappings


Reports


Report Names: Active Clinical Site Closeouts

Clinical Site Closeouts by Product

Clinical Site Closeout by Study Number

128

6. Open Items


129

Clinical Site Initiation

130

Clinical Site Initiation Installation and Configuration Checklist

1. Overview: Clinical Site Initiation

This document is intended to guide users through the process of installing and/or configuring the MasterControl Clinical Site Initiation Solution.

IMPORTANT:







The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with: “_LOAD”





131


Instruction Status




System Identified


Instruction Status




Clinical Site Initiation

Complete

Already installed




Complete

Already installed


If MasterControl Clinical Site Interim solution package is to be used, then select the following SP from the list:

Clinical Site Interim

Complete

Already installed

Not Used



Clinical Deviation

Complete

Already installed

Not Used

132

Instruction Status


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_CT_Clinical_Site_Initiation_Menu.xml. This will create a Clinical Trials menu for this solution.


IMPORTANT NOTE:


Menu(s) installed:

Complete


Install Test Users:



Complete

133

Instruction Status




Enable the route:

Go to Process > Routes. In the Route Name column, locate Clinical Site Initiation.

In the Actions column of the Clinical Site Initiation row, click the Enable Route icon (green check mark) to enable the route.


Default Custom

Clinical Research Assistant (SP_CTSINIT_ClnRsrchAsstnt)

CTSINIT_USER1

Clinical Site Monitor (SP_CTSINIT_ClinicSiteMon)

CTSINIT_USER1

CTSINIT_USER2

Study Director (SP_CTSINIT_StudyDirector)

CTSINIT_USER3

CTSINIT_USER4

Owner (SP_CTSINIT_Owners)

CTSINIT_USER6

Extension Request Approvers (SP_CTSINIT_ERApprovers)

CTSINIT_USER5

Clinical Research Assistant (SP_CTSINIT_ClnRsrchAsstnt)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

Owner (SP_CTSINIT_Owners)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

134

Instruction Status


SPSUBADMIN_User1


___________________________

___________________________

___________________________





Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

135

Instruction Status

If the Clinical Deviation form is to be launched from Clinical Site Initiation form (default):


- Open the Clinical_Site_Initiation.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Deviation form will *not* be launched from Clinical Site Initiation form:


- Open the Clinical_Site_Initiation.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Site Interim form is to be launched from Clinical Site Initiation form (default):

Interim Mode Selection (when INTERIMMODE is set to ‘MC' - which represents Clinical Site Interim form launch):

- Open the Clinical_Site_Initiation.html file in any HTML editor, and search for var INTERIMMODE. Make sure the INTERIMMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Site Interim form will *not* be launched from Clinical Site Initiation form:

Interim Mode Selection (when INTERIMMODE is set to ‘None’ - which represents no Clinical Site Interim form launch):

- Open the Clinical_Site_Initiation.html file in any HTML editor, and search for var INTERIMMODE. Make sure the INTERIMMODE variable is set to “None” in the JS code.

- Save the file.

Complete

N/A

136

Instruction Status







Complete

Default Custom

Dosage Form 1

Dosage Form 2

Dosage Form 3

List items:






Complete

Default Custom

Study 1

Study 2

Study 3

List items:


Complete

137

Instruction Status





Default Custom

Sponsor 1

Sponsor 2

Sponsor 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_RoleInStudy” data structure and review the default options available for the Role In Study drop-down field in the data structure.





Complete

Default Custom


Sub-Investigator

Study Nurse

Study Coordinator

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_InvestigationalProduct” data structure and review the default options available for the Name(s) of Investigational Product(s) (including dosage, and dosage form (if applicable) multi-select list field in the data structure.

Complete

138

Instruction Status





Default Custom

Product1 Dosage1 DosageForm1



List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_IPstorage” data structure and review the default options available for the Where is the IP stored? multi-select list field in the data structure.





Complete

Default Custom

Refrigerated At Required Temperature

Locked Storage Area

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_Indication” data structure and review the default options available for the Indication multi-select list field in the data structure.



Complete

139

Instruction Status



Default Custom

Indication 1

Indication 2

Indication 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_IPLocation” data structure and review the default options available for the IPLocation multi-select list field in the data structure.





Complete

Default Custom

Refrigerator

Freezer

Room

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_IPTempLog” data structure and review the default options available for the IPTempLog multi-select list field in the data structure.





Complete

140

Instruction Status

Default Custom

Manual

Automatic

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_LabDocs” data structure and review the default options available for the LabDocs multi-select list field in the data structure.





Complete

Default Custom

Investigator Brochure (2.1.1)

Protocol (2.1.2)

Protocol Amendment (2.1.4)

Informed Consent Form (2.2.3)

Local Laboratory Certification or Accreditation (5.2.15)

Local Laboratory Normal Ranges (5.2.16)

Certification or Accreditation (8.1.1)

Laboratory Results Documentation (8.1.3)

Normal Ranges (8.1.4)

Lab Manual (8.1.5)

Shipment Records (8.2.2)

Sample Storage Condition Log (8.2.3)

Record of Retained Body Fluids / Tissue Samples (8.2.5)

Relevant Communications (8.3.1)

List items:

141

Instruction Status Other Documents (see comment)

Click the Build Data Structure icon next to the “SP_CFG_CT_LabRoles” data structure and review the default options available for the LabRoles multi-select list field in the data structure.





Complete

Default Custom

Lab Manager

Lab Technician

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_PharmacyDocs” data structure and review the default options available for the PharmacyDocs multi-select list field in the data structure.





Complete

Default Custom


Protocol (2.1.2)


Form FDA 1572 (5.2.8)

Subject Log (5.4.1)

IP Instructions for Handling (6.1.2)

IP Shipment Documentation (6.1.4)

List items:

142

Instruction Status Accountability Documentation (6.1.5)

IP Documentation of Transfer (6.1.6)

Re-labeling Documentation (6.1.7)

IP Recall Documentation (6.1.8)

IP Quality Complaint Form (6.1.9)

IP Documentation Return (6.1.10)

Certificate of Destruction (6.1.11)

Retest and Expiry (6.1.12)

QP (Qualified Person) Certification (6.2.1)

IP Verification Statements (6.2.3)

Treatment Allocation Documentation (6.3.1)

Unblinding Plan (if applicable)(6.3.2)

Treatment Decoding Documentation (6.3.3)

Storage Condition Documentation (6.4.1)

Storage Condition Excursion Documentation (6.4.2)

Non-IP Documentation of Shipment (6.5.2)

Non-IP Documentation of Return (6.5.3)

IRT User Manual (6.6.4)

IRT User Notifications (6.6.5)


Other Documentation (see comment)

Click the Build Data Structure icon next to the “SP_CFG_CT_PharmacyRoles” data structure and review the default options available for the PharmacyRoles multi-select list field in the data structure.





Complete

143

Instruction Status

Default Custom

Pharmacist

Pharmacy Technician

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_SiteSpecificDocs” data structure and review the default options available for the SiteSpecificDocuments multi-select list field in the data structure.





Complete

Default Custom

Site Contact Details (5.1.1)

Confidentiality Agreement (5.1.2)

Acceptance of Investigator Brochure (5.2.1)

Protocol Signature Page (5.2.2)

Protocol Amendment Signature Page (5.2.3)

Principal Investigator Curriculum Vitae (5.2.4)

Sub-Investigator Curriculum Vitae (5.2.5)

Other Curriculum Vitae (5.2.6)

Site and Staff Qualification Supporting Information (5.2.7)

Form FDA 1572 (5.2.8)

Investigator Regulatory Agreement (5.2.9)

Financial Disclosure Form (5.2.10)

Data Privacy Agreement (5.2.11)

List items:

144

Instruction Status Clinical Trial Agreement (5.2.12)

Indemnity (5.2.13)

Other Financial Agreement (5.2.14)



Site Signature Sheet (5.2.18)

Trial Initiation Monitoring Report (5.3.1)

Site Training Documentation (5.3.3)

Subject Log (5.4.1)

Visit Log (5.4.4)

Protocol Deviations (5.4.6)

Financial Documentation (5.4.7)

Notification to Investigators of Safety Information (5.4.9)

Subject Identification Log (5.4.10)

Source Data (5.4.11)

Monitoring Visit Follow-up Letter (5.4.12)


Tracking Information (5.5.2)

Meeting Material (5.5.3)

Pharmacovigilance Database Line Listing (7.1.2)

SAE Report (7.2.2)

Pregnancy Report (7.2.3)

Special Events of Interest (7.2.4)


Completed CRFs (10.2.3)

Documentation of Corrections to Entered Data (10.2.4)

Final Data (10.2.5)

System Account Management (10.4.1)

Technical Design Document (10.4.2)

Validation Documents (10.4.3)

Click the Build Data Structure icon next to the “SP_CFG_CT_StudyDocs” data structure and review the default options available for the StudyDocuments multi-select list field in the data structure.

Complete

145

Instruction Status





Default Custom

Operational Procedures Manual (1.1.5)

Investigator Newsletter (1.1.13)

Investigator Meeting Materials 1.4.3)


Protocol (2.1.2)


Insurance (2.1.6)

Sample Case Report Form (2.1.7)

Subject Diary (2.2.1)

Subject Questionnaire (2.2.2)


Subject Information Sheet (2.2.4)

Subject Participation Card (2.2.5)

Advertisement for Subject Recruitment(2.2.6)

Other Written Information Given to Subjects (2.2.7)

Trial Approval (3.1.2)

Import/Export License (3.2.2)

Site Training Material (5.3.2)

Expedited Safety Report (7.2.1)

CRF Completion Requirements (10.2.1)

List items:

146

Instruction Status

Notes

147






Form InfoCard Types: Clinical Site Initiation

Form Numbering Series: Clinical Site Initiation Form (CSI-xxxxx)






Form Vaults: Clinical Site Initiation Draft

Clinical Site Initiation Release

Clinical Site Initiation Archive

Aborted Forms

Form Lifecycle: Clinical Site Initiation Forms

Roles

Roles: Clinical Research Assistant (SP_CTSINIT_ClnRsrchAsstnt)




Owners (SP_CTSINIT_Owners)


148




Route: Clinical Site Initiation

149

Data Structures





SP_CFG_CT_Sponsor


SP_CFG_CT_InvestigationalProduct

SP_CFG_CT_IPLocation

SP_CFG_CT_IPstorage

SP_CFG_CT_TempLog

SP_CFG_CT_LabDocs

SP_CFG_CT_LabRoles

SP_CFG_CT_PharmacyDocs

SP_CFG_CT_PharmacyRoles

SP_CFG_CT_SiteSpecificDocs

SP_CFG_CT_StudyDocs

SP_TRANS_CINITIATION

Template Mappings

The following template mappings are created by the installer associated with the Clinical Site Initiation Solution Package. Refer to the Design Specification (SP-793) for the template mapping detail:

SiteInitiation-ActionItem

SiteInitiation-ClinicalDev

SiteInitiation-ExtRequest

SiteInitiation-InterimVisit

EventCard Mappings


Reports

150


Report Names: Closed Clinical Site Initiations

Active Clinical Site Initiations

Clinical Site Initiations by Product

Clinical Site Initiations by Study Number

151

6. Open Items


152


153

Clinical Site Interim Installation and Configuration Checklist

1. Overview: Clinical Site Interim

This document is intended to guide users through the process of installing and/or configuring the MasterControl Clinical Site Interim Solution.

IMPORTANT:







The installation will create a multitude of records, including numbering series, InfoCard Types, vaults, lifecycles, routes and more. Whenever a record with the same name or identifier already exists, the installer will create a new record and append the name or identifier with “_LOAD.”





154


Instruction Status




System Identified


Instruction Status





Complete

Already installed




Complete

Already installed


If MasterControl Clinical Site Interim solution package is to be used, then select the following SP from the list:


Complete

Already installed

Not Used

155

Instruction Status



Clinical Deviation

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_CT_Clinical_Site_Interim_Menu.xml. This will create a Clinical Trials menu for this solution.


IMPORTANT NOTE:


Menu(s) installed:

Complete

156

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Clinical Site Interim.

In the Actions column of the Clinical Site Interim row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Clinical Research Assistant (SP_CTSINTE_ClnRsrchAsstnt)

CTSINTE_USER1

Clinical Site Monitor (SP_CTSINTE_ClinicSiteMon)

CTSINTE_USER1

CTSINTE_USER2

Study Director (SP_CTSINTE_StudyDirector)

CTSINTE_USER3

CTSINTE_USER4

Clinical Research Assistant (SP_CTSINTE_ClnRsrchAsstnt)

__________________________

__________________________

__________________________


__________________________

__________________________

__________________________


157

Instruction Status

Extension Request Approvers (SP_CTSINTE_ERApprovers)

CTSINTE_USER5


SPSUBADMIN_User1

__________________________

__________________________

__________________________


__________________________

__________________________

__________________________


__________________________

__________________________

__________________________





Notes

158

Instruction Status


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

If the Clinical Deviation form is to be launched from Clinical Site Interim form (default):


- Open the Clinical_Site_Interim.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

159

Instruction Status

If the Clinical Deviation form will *not* be launched from Clinical Site Interim form:


- Open the Clinical_Site_ Interim.html file in any HTML editor, and search for var DEVIATIONMODE. Make sure the DEVIATIONMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Site Closeout form is to be launched from Clinical Site Interim form (default):

Closeout Mode Selection (when CLOSEOUTMODE is set to ‘MC' - which represents Clinical Site Closeout form launch):

- Open the Clinical_Site_Interim.html file in any HTML editor, and search for var CLOSEOUTMODE. Make sure the CLOSEOUTMODE variable is set to “MC” in the JS code.

- Save the file.

Complete

N/A

If the Clinical Site Closeout form will *not* be launched from Clinical Site Interim form:

Closeout Mode Selection (when CLOSEOUTMODE is set to ‘None’ - which represents no Clinical Site Closeout form launch):

- Open the Clinical_Site_ Interim.html file in any HTML editor, and search for var CLOSEOUTMODE. Make sure the CLOSEOUTMODE variable is set to “None” in the JS code.

- Save the file.

Complete

N/A







Complete

Default Custom

160

Instruction Status

Dosage Form 1

Dosage Form 2

Dosage Form 3

List items:





Click the Cancel button from the toolbar and then click the OK button on the confirmation message stating: “If you cancel, all changes will be lost. Do you wish to cancel?” Complete

Default Custom

Study 1

Study 2

Study 3

List items:






Complete

Default Custom

Sponsor 1

Sponsor 2

Sponsor 3

List items:

161

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CT_RoleInStudy” data structure and review the default options available for the Role In Study drop-down field in the data structure.





Complete

Default Custom


Sub-Investigator

Study Nurse

Study Coordinator

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_StudyNumber” data structure and review the default options available for the StudyNumber drop-down field in the data structure.





Complete

Default Custom

Study 1

Study 2

Study 3

List items:

162

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CT_EventName” data structure and review the default options available for the EventName drop-down field in the data structure.





Complete

Default Custom

Last Visit Date (Visit # in Comment)

Screening Date

Enrollment Date

Withdrawal Date

Drop-out Date

Death Date

Initial Treatment Date

Follow-up Treatment Date

Visit Date (Visit # in Comment)

Informed Consent Signed (Version in Comment)

Other Dated Event (See Comment)

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_Gender” data structure and review the default options available for the Gender drop-down field in the data structure.





Complete

Default Custom

163

Instruction Status

Male

Female

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_Indication” data structure and review the default options available for the Indication drop-down field in the data structure.





Complete

Default Custom

Indication 1

Indication 2

Indication 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_IPLocation” data structure and review the default options available for the IPLocation drop-down field in the data structure.





Complete

Default Custom

Refrigerator

Freezer

Room

List items:

164

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_CT_IPTempLog” data structure and review the default options available for the IPTempLog drop-down field in the data structure.





Complete

Default Custom

Manual

Automatic

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_LabDocs” data structure and review the default options available for the LabDocs drop-down field in the data structure.





Complete

Default Custom


Protocol (2.1.2)





Certification or Accreditation (8.1.1)

List items:

165

Instruction Status Laboratory Results Documentation (8.1.3)

Normal Ranges (8.1.4)

Lab Manual (8.1.5)

Shipment Records (8.2.2)

Sample Storage Condition Log (8.2.3)

Record of Retained Body Fluids / Tissue Samples (8.2.5)


Other Documents (see comment)

Click the Build Data Structure icon next to the “SP_CFG_CT_LabRoles” data structure and review the default options available for the LabRoles drop-down field in the data structure.





Complete

Default Custom

Lab Manager

Lab Technician

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_PatientDocs” data structure and review the default options available for the PatientDocs drop-down field in the data structure.





Complete

Default Custom

166

Instruction Status




Subject Information Sheet (2.2.4 )


Subject Log (5.4.1)

Visit Log (5.4.4)



Other Patient Documentation (see comment)

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_PharmacyDocs” data structure and review the default options available for the PharmacyDocs drop-down field in the data structure.





Complete

Default Custom


Protocol (2.1.2)


Form FDA 1572 (5.2.8)

Subject Log (5.4.1)

IP Instructions for Handling (6.1.2)

IP Shipment Documentation (6.1.4)

Accountability Documentation (6.1.5)

IP Documentation of Transfer (6.1.6)

Re-labeling Documentation (6.1.7)

List items:

167

Instruction Status IP Recall Documentation (6.1.8)

IP Quality Complaint Form (6.1.9)

IP Documentation Return (6.1.10)

Certificate of Destruction (6.1.11)

Retest and Expiry (6.1.12)

QP (Qualified Person) Certification (6.2.1)

IP Verification Statements (6.2.3)

Treatment Allocation Documentation (6.3.1)

Unblinding Plan (if applicable)(6.3.2)

Treatment Decoding Documentation (6.3.3)

Storage Condition Documentation (6.4.1)

Storage Condition Excursion Documentation (6.4.2)

Non-IP Documentation of Shipment (6.5.2)

Non-IP Documentation of Return (6.5.3)

IRT User Manual (6.6.4)

IRT User Notifications (6.6.5)


Other Documentation (see comment)

Click the Build Data Structure icon next to the “SP_CFG_CT_PharmacyRoles” data structure and review the default options available for the PharmacyRoles drop-down field in the data structure.





Complete

Default Custom

List items:

168

Instruction Status Pharmacist

Pharmacy Technician

Other

Click the Build Data Structure icon next to the “SP_CFG_CT_Race” data structure and review the default options available for the Race drop-down field in the data structure.





Complete

Default Custom

White

Black

Latino

Asian

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_RecruitmentActivity” data structure and review the default options available for the Recruitment Activity drop-down field in the data structure.





Complete

Default Custom

Randomized List items:

169

Instruction Status Enrolled (actual)

Enrollment (expected)

Screened

Withdrawn

Dropped Out

Other

Click the Build Data Structure icon next to the “SP_CFG_CT_SAEActionsTaken” data structure and review the default options available for the SAEActionsTaken drop-down field in the data structure.





Complete

Default Custom

No action required

Amend consent document

Amend protocol

Inform current subjects

Terminate or suspend protocol

Other (see comments)

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_SAECategory” data structure and review the default options available for the SAECategory drop-down field in the data structure.





Complete

170

Instruction Status

Default Custom

Death

Disability/Incapacity

Life Threatening

Congenital Anomaly/Birth Defect

Hospitalization-Initial or Prolonged

Intervention to Prevent Permanent Impairment

Other (See comment)

List items:

Click the Build Data Structure icon next to the “SP_CFG_CT_SiteSpecificDocs” data structure and review the default options available for the SiteSpecificDocs drop-down field in the data structure.





Complete

Default Custom

Site Contact Details (5.1.1)

Confidentiality Agreement (5.1.2)

Acceptance of Investigator Brochure (5.2.1)

Protocol Signature Page (5.2.2)

Protocol Amendment Signature Page (5.2.3)

Principal Investigator Curriculum Vitae (5.2.4)

Sub-Investigator Curriculum Vitae (5.2.5)

Other Curriculum Vitae (5.2.6)

Site and Staff Qualification Supporting Information (5.2.7)

Form FDA 1572 (5.2.8)

List items:

171

Instruction Status Investigator Regulatory Agreement (5.2.9)

Financial Disclosure Form (5.2.10)

Data Privacy Agreement (5.2.11)

Clinical Trial Agreement (5.2.12)

Indemnity (5.2.13)

Other Financial Agreement (5.2.14)



Site Signature Sheet (5.2.18)

Trial Initiation Monitoring Report (5.3.1)

Site Training Documentation (5.3.3)

Subject Log (5.4.1)

Visit Log (5.4.4)

Protocol Deviations (5.4.6)

Financial Documentation (5.4.7)

Notification to Investigators of Safety Information (5.4.9)

Subject Identification Log (5.4.10)

Source Data (5.4.11)

Monitoring Visit Follow-up Letter (5.4.12)


Tracking Information (5.5.2)

Meeting Material (5.5.3)

Pharmacovigilance Database Line Listing (7.1.2)

SAE Report (7.2.2)

Pregnancy Report (7.2.3)

Special Events of Interest (7.2.4)




172

Instruction Status Final Data (10.2.5)

System Account Management (10.4.1)

Technical Design Document (10.4.2)

Validation Documents (10.4.3)

Click the Build Data Structure icon next to the “SP_CFG_CT_StudyDocs” data structure and review the default options available for the StudyDocs drop-down field in the data structure.





Complete

Default Custom

Operational Procedures Manual (1.1.5)

Investigator Newsletter (1.1.13)

Investigator Meeting Materials 1.4.3)


Protocol (2.1.2)


Insurance (2.1.6)

Sample Case Report Form (2.1.7)




Subject Information Sheet (2.2.4)


Advertisement for Subject Recruitment(2.2.6)

Other Written Information Given to Subjects (2.2.7)

List items:

173

Instruction Status Trial Approval (3.1.2)

Import/Export License (3.2.2)

Site Training Material (5.3.2)

Expedited Safety Report (7.2.1)

CRF Completion Requirements (10.2.1)

Click the Build Data Structure icon next to the “SP_CFG_CT_Submissions” data structure and review the default options available for the Submissions drop-down field in the data structure.





Complete

Default Custom

IRB/IEC Submission (4.1.1)

IRB/IEC Approval (4.1.2)

IRB/IEC Composition (4.1.3)

IRB/IEC Documentation of Non-Voting Status (4.1.4 )

IRB/IEC GCP Compliance Statement (4.1.5)

Other Submissions (4.2.1)

Other Approvals (4.2.2)

Notification to IRB/IEC of Safety Information (4.3.1)

IRB/IEC Progress Report (4.3.2)

IRB/IEC Notification of Trial Termination (4.3.3)


List items:

174

Notes

175






Form InfoCard Types: Clinical Site Interim

Form Numbering Series: Clinical Site Interim Form (CSInter-xxxxx)






Form Vaults: Clinical Site Interim Draft

Clinical Site Interim Release

Clinical Site Interim Archive

Aborted Forms

Form Lifecycle: Clinical Site Interim Forms

Roles

Roles: Clinical Research Assistant (SP_CTSINTE_ClnRsrchAsstnt)







Route: Clinical Site Interim

176

Data Structures



SP_CFG_CT_EventName

SP_CFG_CT_Gender


SP_CFG_CT_IPLocation

SP_CFG_CT_IPTempLog

SP_CFG_CT_LabDocs

SP_CFG_CT_LabRoles

SP_CFG_CT_PatientDocs

SP_CFG_CT_PharmacyDocs

SP_CFG_CT_PharmacyRoles

SP_CFG_CT_Race

SP_CFG_CT_RecruitmentActivity


SP_CFG_CT_SAEActionsTaken

SP_CFG_CT_SAECategory

SP_CFG_CT_SiteSpecificDocs

SP_CFG_CT_Sponsor


SP_CFG_CT_StudyDocs


SP_CFG_CT_Submissions

SP_CFG_CT_CINTERIM

Template Mappings

The following template mappings are created by the installer associated with the Clinical Site Interim Solution Package. Refer to the Design Specification (SP-794) for the template mapping detail:

SiteInterim-ActionItem

SiteInterim-ExtRequest

SiteInterim-SiteCloseout

SiteInterim-ClinicalDeviation

SiteInterim-SiteInterimFollowUp

EventCard Mappings

177


Reports


Report Names: Active Clinical Site Interims by Study Number

Clinical Site Interims by Product

178

6. Open Items


179

Customer Complaint Advanced

180

Customer Complaint Advanced Installation and Configuration Checklist

1. Overview: Customer Complaint Advanced

This document is intended to guide users through the process of installing and/or configuring the MasterControl Customer Complaint Advanced Solution.

IMPORTANT:














181


Instruction Status



_____


System Identified


Instruction Status




Customer Complaint Advanced Complete

Already installed




Complete

Already installed


If MasterControl eMDR solution package is to be used, then select the following SP from the list:

eMDR

Complete

Already installed

Not Used

182

Instruction Status



CAPA Essentials

Complete

Already installed

Not Used



CAPA Advanced

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








Complete

183

Instruction Status

IMPORTANT NOTE:


Menu(s) installed:


Install Test Users:

Go to Portal > Loading > Users to view a list of available users to install. To choose which users to install, refer to the Default column below. Select these users on the Loading > Users window in MasterControl. It may take several seconds to complete the installation.


Go to Portal > User Management > Roles then click the Edit icon next to each role and in edit security role window make sure that the test users have been associated with their appropriate roles as indicated in the Default column.



Enable the route:

Go to Process > Routes. In the Route Name column, locate Customer Complaint Adv.

In the Actions column of the Customer Complaint Adv row, click the Enable Route icon (green check mark) to enable the route.


Complete

184

Instruction Status

Default Custom

Complaint Coordinator (SP_COMP_Coordinator)

COMP_USER1

Complaint Users (SP_COMP_Users)

COMP_USER2

COMP_USER3

Task Owners (SP_COMP_TaskOwners)

COMP_USER4

COMP_USER5

COMP_USER6

Extension Request Approvers (SP_COMP_ExtReqApprovers)

COMP_USER7

COMP_USER8


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________






185

Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

If the CAPA Essentials form is to be launched from Customer Complaint Advanced form:

CAPA Type Selection (when CAPATYPE is set to ‘1’ - which represents CAPA Essentials form launch):

- Open the Customer_Complaint.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

186

Instruction Status

If the CAPA Advanced (Issue Review) is to be launched from Customer Complaint Advanced (default):

CAPA Type Selection (when CAPATYPE is set to ‘2’ - which represents CAPA Advanced (Issue Review) form launch):


- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from Customer Complaint Advanced:

CAPA Type Selection (when CAPATYPE is set to ‘0’ - which represents no CAPA form launch, and the reference field is editable):


- Save the file.

Complete

N/A

If the eMDR form is to be launched from Customer Complaint Advanced (default):

eMDR Type Selection (when EMDRTYPE is set to ‘1’ - which represents eMDR form launch):

- Open the Customer_Complaint.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the eMDR form will *not* be launched from Customer Complaint Advanced:

eMDR Type Selection (when EMDRTYPE is set to ‘0’ - which represents no eMDR form launch, and the reference field is editable):

- Open the Customer_Complaint.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

187

Instruction Status

If the Customer Complaint Advanced form is to be configured for eMDR reporting (default):

Report Type Selection: - Open the Customer_Complaint.html file in any HTML editor, and

search for var REPORTEMDR. Make sure the REPORTEMDR variable is set to “true” in the JS code.

- Save the file. Note: When REPORTEMDR is set to ‘true’ - it enables the MDR sub-tab (which is within the Event Reporting (T3) tab) of the Customer Complaint Advanced form. When REPORTEMDR is set to ‘false’ – the tab is not shown.

Complete

N/A

If the Customer Complaint Advanced form is to be configured for EU (Europe) Vigilance reporting (default):


search for var REPORTEUROPE. Make sure the REPORTEUROPE variable is set to “true” in the JS code.

- Save the file. Note: When REPORTEUROPE is set to ‘true’ - it enables the Vigilance-EU sub-tab (which is within the Event Reporting (T3) tab) of the Customer Complaint Advanced form. When REPORTEUROPE is set to ‘false’ – the tab is not shown.

Complete

N/A

If the Customer Complaint Advanced form is to be configured for CAN (Canada) Vigilance reporting (default):


search for var REPORTCANADA. Make sure the REPORTCANADA variable is set to “true” in the JS code.

- Save the file. Note: When REPORTCANADA is set to ‘true’ - it enables the Vigilance-CAN sub-tab (which is within the Event Reporting (T3) tab) of the Customer Complaint Advanced form. When REPORTCANADA is set to ‘false’ – the tab is not shown.

Complete

N/A

188

Instruction Status


Click the Build Data Structure icon next to the “SP_CFG_Complaint_Adv_Source” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Company Website

Email

Phone

Fax

Mail

In Person

Incident Report

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_Complaint_Adv_Category” data structure and review the default options available for the Category drop-down field in the data structure.





Complete

Default Custom

Consumer

Pharmacist

List items:

189

Instruction Status Physician

Supplier

Click the Build Data Structure icon next to the “SP_CFG_Complaint_Adv_Countries” data structure and review the default options available for the Country drop-down field in the data structure.





Complete

Default Custom

United States of America

Canada

Mexico

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_Complaint_Adv_Justification” data structure and review the default options available for the Justification drop-down field in the data structure.





Complete

Default Custom

Product is not manufactured by the Company receiving the complaint

Complaint is not a failure of the device, labeling/packaging to meet specs

Firm is unable to obtain the device for analysis

Other

List items:

190

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_Complaint_Adv_InvestigationOutcome” data structure and review the default options available for the Investigation Outcome drop-down field in the data structure.



Note: Make sure the “Other" option remains unchanged in the default options of the “SP_CFG_Complaint_Adv_InvestigationOutcome” data structure during setup.



Complete

Default Custom

Investigation Initiated

Investigation Complete

Not Investigated

Corrective Action Initiated

Corrective Action Complete

Other

List items:

The following three sections cover review and customization of the Event Reporting (T3) sub-tabs; MDR, Vigilance-EU, and Vigilance-CAN.

191

MDR

Event Reporting (T3), MDR sub-tab

MDR/Adverse Event Evaluation questions/options

You can review the questions to see if you need to modify, add, or delete them.

In MasterControl, select Portal > Data Structure.

Find the SP_CFG_Complaint_Adv_Decision_Tree data structure.

Click the Build Data Structure icon next to the SP_CFG_Complaint_Adv_Decision_Tree data structure.

In the en_us column, review the default questions/options for each question set within the MDR sub-tab.

Important: Below you will find the default questions with their corresponding lang_key that are specific to the MDR sub-tab questions/options. There is also space for you to write custom questions/options that you might use to replace the original question/option.

After reviewing:

To keep the questions/options as is, click Cancel on the toolbar.

To modify a question/option, replace the default text with your own text.

To remove a question/option, click the Delete icon to the right of the question. You can also replace question text with N/A to remove the question.

To add a question, click one of the Add New Line icons to the right of the questions. The new question is added at the end of the questions. You can also replace N/A with text to add a question to a particular section.

After you have finished updating the questions/options, click Save on the toolbar.

The following area shows the language key (lang_key) along with its associated question/option found in the SP_CFG_Complaint_Adv_Decision_Tree data structure. You can use this area to review and/or prepare to modify the questions/options.

Complete

Default for MDR sub-tab Custom

Question set A On the form, these follow “Has a death occurred?” when “Yes” is selected.

MDR_US_A1

Is there a reasonable possibility that a device failure or malfunction was a direct or indirect factor in the death?

MDR_US_A2

Is there a reasonable possibility that a device design defect was a direct or indirect factor in the death?

MDR_US_A3

Is there a reasonable possibility that the device labeling was a direct or indirect factor in the death?

Question set A

(Use this area for your custom questions/options.)

192

MDR_US_A4

Is there a reasonable possibility that the failure of the device user to follow operational instructions was a direct or indirect factor in the death?

MDR_US_A5

N/A

Question set B These follow “Has an injury occurred?” when “Yes” is selected.

MDR_US_B1

Was this injury life threatening?

MDR_US_B2

Has this injury resulted in the permanent impairment of a body function or permanent damage to body structure?

MDR_US_B3

Did the injury necessitate medical or surgical intervention to preclude permanent impairment or damage?

MDR_US_B4

N/A

MDR_US_B5

N/A

Question set C These follow “Has a malfunction occurred?” when “Yes” is selected.

MDR_US_C1

Is there more than a remote chance that a recurrence of the malfunction would cause a death or serious injury?

MDR_US_C2

Do the consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury?

MDR_US_C3

Does the malfunction result in the failure of the device to perform its essential function and compromise the device’s therapeutic, monitoring, or diagnostic effectiveness, which could cause or contribute to a death or serious injury?

MDR_US_C4

Does the malfunction involve a long-term implant or device that is considered to be life supporting or life sustaining?

MDR_US_C5

Is the manufacturer required to take action under section 518 (notification, repair, replacement or refund, recalls) or section 519(f) (reports of removals and corrections)

Question set B

Question set C

193

of the FD&C Act as a result of the malfunction of the device or similar devices?

Vigilance-EU

Event Reporting (T3), Vigilance-EU sub-tab

Vigilance questions/options





In the en_us column, review the default questions/options for each question set within the Vigilance-EU sub-tab.

Important: Below you will find the default questions with their corresponding lang_key that are specific to the Vigilance-EU questions/options. There is also space for you to write custom questions/options that you might use to replace the original question/option.

After reviewing:







Complete

194

Default for Vigilance-EU sub-tab Custom

Question set A On the form, these follow “A. An event has occurred.”

MDR_EU_A1

A malfunction or deterioration in the characteristics or performance

MDR_EU_A2

False positive or false negative test result falling outside the declared performance of the test

MDR_EU_A3

Unanticipated adverse reaction or unanticipated side effect

MDR_EU_A4

Interactions with other substances or products

MDR_EU_A5

Degradation/destruction of the device (e.g. fire)

MDR_EU_A6

Inappropriate therapy

MDR_EU_A7

An inaccuracy in the labeling, instructions for use and/or promotional materials

MDR_EU_A8

N/A

MDR_EU_A9

N/A

MDR_EU_A10

N/A

Question set B These follow “B. The MANUFACTURER’S device is suspected to be a contributory cause of the INCIDENT: Based on”

MDR_EU_B1

The opinion, based on available evidence, of healthcare professionals

MDR_EU_B2

The results of the MANUFACTURER'S own preliminary assessment of the incident

MDR_EU_B3

Evidence of previous, similar INCIDENTs

MDR_EU_B4

Other evidence held by the MANUFACTURER

MDR_EU_B5

N/A

Question set C

Question Set A


Question set B

Question set C

195

These follow “C. The even led, or might have led, to one of the following outcomes”

MDR_EU_C1

Death of a patient, User or other person

MDR_EU_C2

Serious deterioration in the state of health of a patient, USER or other person. A serious deterioration in state of health can include

Checkboxes set C These follow question “C.2. Serious deterioration in the state of health of a patient, USER or other person. A serious deterioration in state of health can include”

MDR_EU_CHECKBOXC1

Life-threatening illness

MDR_EU_CHECKBOXC2

Permanent impairment of a body function or permanent damage to a body structure

MDR_EU_CHECKBOXC3

A condition necessitating medical or surgical intervention to prevent life-threatening illness or permanent impairment of a body function or permanent damage to a body structure

MDR_EU_CHECKBOXC4

Any indirect harm as a consequence of an incorrect diagnostic or IVD test results when used within the MANUFACTURER'S instructions for use

MDR_EU_CHECKBOXC5

Foetal distress, foetal death or any congenital abnormality or birth defects

Questions for “Review for Exclusion” section These are in the “Review for Exclusion” section

EMEA_RFERadio1

Did the incident occur outside the EEA and Switzerland and did not lead to a Field Safety Corrective Action (FSCA) in the relevant geographic region?

EMEA_RFERadio2

Deficiency of a device found by the USER prior to use

EMEA_RFERadio3

Event caused by patient conditions

EMEA_RFERadio4

Service life or shelf life of the medical device exceeded

EMEA_RFERadio5

Protection against a fault functioned correctly

EMEA_RFERadio6

Expected and foreseeable side effects

Checkboxes set C

Questions for “Review for Exclusion”

196

EMEA_RFERadio7

Negligible likelihood of occurrence of death or serious deterioration in state of health

Canada-EU

Event Reporting (T3), Vigilance-CAN sub-tab

Vigilance questions/options





In the en_us column, review the default questions/options for each question set within the Vigilance-CAN sub-tab.

Important: Below you will find the Default questions with their corresponding lang_key that are specific to the Vigilance-CAN questions/options. There is also space for you to write custom questions/options that you might use to replace the original question/option.

After reviewing:







Complete

197

Default for Vigilance-CAN sub-tab Custom

Checkboxes section 2.4.2 On the form, these follow “2.4.2. The device contributed to the incident. In assessing the link between the device and the incident, the reporter should take into account.”

CAN242CHECKBOX1

The Opinion, based on available information, from a health professional

CAN242CHECKBOX2

Information concerning previous, similar incidents

CAN242CHECKBOX3

Complaint Trends

CAN242CHECKBOX4

Any other information held by the reporter

Questions section 2.4.3 These follow “2.4.3. The incident lead to one of the following outcomes”

CAN2431Radio

Death of a patient, user or other person

CAN2432Radio

Serious deterioration in health of patient, user or other person

Checkboxes section 2.4.3.2 These follow “2.4.3.2. Serious deterioration in health of patient, user or other person”

CAN243CHECKBOX1

Life threatening disease

CAN243CHECKBOX2

Disorder or abnormal physical state

CAN243CHECKBOX3

The permanent impairment of a body function or permanent damage to a body structure

CAN243CHECKBOX4

A condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage

Checkboxes section 2.4.3.3 This follows the previous checkbox.

CAN2433Radio

Potential for death or serious deterioration in health of a patient, user or other person

Checkboxes section 2.4.2


Questions section 2.4.3

Checkboxes section 2.4.3.2

Checkboxes section 2.4.3.3

198

Checkboxes for “Review for Exclusion” section These are in the “Review for Exclusion” section

CANRFECHECKBOX1

Foreign incidents which occurred prior to the specific incident which resulted in the decision to report a corrective action to a foreign regulatory authority

CANRFECHECKBOX2

Deficiencies in a device that would always be detected by the user and where death and serious deterioration in health has not occurred

CANRFECHECKBOX3

Incident caused by a patient's condition where the root cause of the incident is definitely due solely to a patient's condition

CANRFECHECKBOX4

Malfunction protection operated correctly and did not lead to a death or to a serious deterioration in health

CANRFECHECKBOX5

Abnormal/off label use-Abnormal use includes intentional use for a non-approved purpose ("off-label" use). It should not be confused with use error (see section 2.7). As with all reported device complaints, all potential abnormal use incidents must be evaluated by the reporter (see Appendix A for examples). Abnormal use need not be reported to Health Canada under mandatory reporting regulations. Abnormal use should be managed by the health care facility and the appropriate provincial or territorial departments of health under specific and appropriate schemes not covered by this document

CANRFECHECKBOX6

Incidents occurring outside of Canada and in which the product is not authorized for sale in Canada and has not been previously authorized for sale in Canada

Checkboxes for “Review for Exclusion”

Check In the template InfoCard you previously checked out and load the modified Customer Complaint HTML file as the template’s main file, and then click on the Form Fields tab.


Mark the route available by clicking the “Make Route Available” icon next to the route and the solution package is ready for use.

Complete

199

Notes

200






Form InfoCard Types: Customer Complaint

Form Numbering Series: Customer Complaint Form (Complaint-xxxx)






Form Vaults: Customer Complaint Inprocess

Customer Complaint Complete

Customer Complaint Archive

Aborted Forms

Form Lifecycle: Customer Complaint Forms

Roles

Roles: Complaint Coordinator (SP_COMP_Coordinator)







Route: Customer Complaint Adv

201

Data Structures

Data Structures: Customers

Products

SP_CFG_Complaint_Adv_Source

SP_CFG_Complaint_Adv_Category

SP_CFG_Adv_Countries

SP_CFG_Complaint_Adv_Justification

SP_CFG_Complaint_Adv_InvestigationOutcome

SP_TRANS_HCOMP

SP_CFG_Complaint_Adv_Decision_Tree

Template Mappings

The following template mappings are created by the installer associated with the Customer Complaint Advanced Solution Package. Refer to the Design Specification (SP-795) for the template mapping detail:

ComplaintAdv-ActionItem

ComplaintAdv-Ext Request

ComplaintAdv-CAPA

ComplaintAdv-IssueReview

ComplaintAdv-eMDR

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Customer Complaint Advanced Solution Package. Refer to the Design Specification (SP-795) for the EventCard mapping detail:

ComplaintAdv_Agent

ComplaintAdv_Event

202

Reports


Report Names: Customer Complaint Summary

Customer Complaints In-Process

Customer Complaints by Type

Customer Complaints by Product

Customer Complaints 1-Year Trend

203

6. Open Items


204

Customer Complaint Essentials

205

Customer Complaint Essentials Installation and Configuration Checklist

1. Overview: Customer Complaint Essentials

This document is intended to guide users through the process of installing and/or configuring the MasterControl Customer Complaint Essentials Solution.

IMPORTANT:









configuration. Consult the Installation Items section for a list of records that the installer will





206


Instruction Status




System Identified


Instruction Status





Complete

Already installed




Complete

Already installed

207

Instruction Status



CAPA Essentials


CAPA Advanced


eMDR

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Complete

208

Instruction Status

Menu(s) installed:


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Customer Complaint.

In the Actions column of the Customer Complaint row, click the Enable Route icon (green check mark) to enable the route.


Complete

209

Default Custom


COMP_USER1


COMP_USER2

COMP_USER3


COMP_USER4

COMP_USER5

COMP_USER6

Extension Request Approvers (SP_COMP_ERApprovers)

COMP_USER9

COMP_USER10


SPSUBADMIN_User1


______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________




If configuration is required, then the Post-Installation Configuration

section needs to be completed.



210

Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

211

Instruction Status


Click the Build Data Structure icon next to the “Products” data structure, and review the default options available for the Product drop-down field in the data structure.






Complete

N/A

212

Instruction Status

Click the Build Data Structure icon next to the “SP_CFG_Complaint_ComplaintSource” data structure, and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Company Website

Email

Fax

In Person

Incident Report

Third-Party

Verbal

Written

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_Complaint_Category” data structure, and review the default options available for the Category drop-down field in the data structure.





Complete

Default Custom

Consumer

Pharmacist

Physician

Supplier

List items:

213

Instruction Status

“MDR/Adverse Event Evaluation” Questions Settings:

Click the Build Data Structure icon next to the “SP_TRANS_COMP” data structure, and review the default options available for the “MDR/Adverse Event Evaluation” questions by searching the T2_L25, T2_L26 and T2_L27 fields in the lang_key column of the data structure.

If changes are required in the default data structure options for the “MDR/Adverse Event Evaluation” questions:

Change the default options for the “MDR/Adverse Event Evaluation” questions in the data structure as follows and click the Save button from the toolbar.

If want to edit a question:

To edit a question insert text in English and French language in the en_us and fr_fr column respectively as question’s default text corresponding to the question’s relevant field in the lang_key column of the data structure.

If want to remove a question:

To remove a question, insert N/A as question’s default text in both en_us and fr_fr columns corresponding to the question’s relevant field in the lang_key column of the data structure.

If changes are not required in the default data structure options for the “MDR/Adverse Event Evaluation” questions:


Complete

Default Custom

Did the event result in medical intervention to prevent permanent impairment or death?

Is there a reasonable expectation that the type of observed failure could result in permanent impairment or death?

Did a death occur?

List items:

Search for CC Country in html source.

Review the drop-down options on the Country field. These options can be changed in the field’s option attribute, if desired.

Note: Make sure the "United States of America" remains unchanged and on top of the drop-down options configured during setup.

Complete

214

Default Custom

(blank)

United States of America

Canada

Mexico

Other

List items:

If CAPA Advanced (Issue Review) is to be launched from Customer Complaint Essentials (default):

CAPA Type Selection (when CAPATYPE is set to ‘1' - which represents CAPA Advanced (Issue Review) form launch):

- Open the Complaint.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from Customer Complaint Essentials form:

CAPA Type Selection (when CAPATYPE is set to ‘2' - which represents CAPA Essentials form launch):


- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from Customer Complaint Essentials:



- Save the file.

Complete

N/A

If the eMDR form is to be launched from Customer Complaint Essentials (default):

eMDR Type Selection (when EMDRTYPE is set to ‘1’ - which represents eMDR form launch):

- Open the Complaint.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

215

If the eMDR form will *not* be launched from Customer Complaint Essentials:

eMDR Type Selection (when EMDRTYPE is set to ‘0’ - which represents no eMDR form launch, and the reference field is editable):

- Open the Complaint.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

Check in the template InfoCard you previously checked out and load the modified HTML file, and then click on the Form Fields tab.


Mark the route available by clicking the “Make Route Available” icon next to the route. The solution package is ready for use.

Complete

Notes

216






Form InfoCard Types: Customer Complaint

Form Numbering Series: Customer Complaint Form (Complaint-xxxx)






Form Vaults: Customer Complaint Inprocess

Customer Complaint Complete

Customer Complaint Archive

Aborted Forms

Form Lifecycle: Customer Complaint Forms

Roles

Roles: Complaint Coordinator (SP_COMP_Coordinator)







Route: Customer Complaint

217

Data Structures


Customers

Products

SP_CFG_Complaint_ComplaintSource

SP_CFG_Complaint_Category

SP_TRANS_COMP

Template Mappings

The following template mappings are created by the installer associated with the Customer Complaint Essentials Solution Package. Refer to the Design Specification (SP-796) for the template mapping detail:

Complaint-ExtRequest

Complaint-ActionItem

Complaint-CAPA

Complaint-eMDR

Complaint-IssueReview

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Customer Complaint Essentials Solution Package. Refer to the Design Specification (SP-796) for the EventCard mapping detail:

Complaint_Agent

Complaint_Event

218

Reports


Report Names: Customer Complaint Summary

Customer Complaints In-Process

Customer Complaints by FxI Score

Customer Complaints by Category

Customer Complaints by Product

Customer Complaints 1-Year Trend

219

6. Open Items


220

Deviation

221

Deviation Installation and Configuration Checklist

1. Overview: Deviation

This document is intended to guide users through the process of installing and/or configuring the MasterControl Deviation Solution.

IMPORTANT:












222


Instruction Status




System Identified


Instruction Status




Deviation Complete

Already installed

The following other form process is included in this solution as required add-ons and need to be installed prior to use:


Complete

Already installed




Complete

Already installed

Not Used



CAPA Essentials

Complete

Already installed

Not Used

223

Instruction Status



CAPA Advanced

Complete

Already installed

Not Used


If MasterControl Nonconformance solution package is to be used, then select the following SP from the list:

Nonconformance

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








Complete

224

Instruction Status

IMPORTANT NOTE:


Menu(s) installed:


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Deviation.

In the Actions column of the Deviation row, click the Enable Route icon (green check mark) to enable the route.


Complete

225

Instruction Status

Default Custom

Deviation Coordinator (SP_DEV_Coordinator)

DEV_USER1

Deviation Users (SP_DEV_Users)

DEV_USER2

DEV_USER3

Technical Review Role (SP_DEV_Technical)

DEV_USER4

DEV_USER5

Production Role (SP_DEV_Production)

DEV_USER6

DEV_USER7

Quality Assurance Role (SP_DEV_QA)

DEV_USER8

DEV_USER9

Extension Request Approvers (SP_DEV_ERApprovers)

DEV_USER10

DEV_USER11


SPSUBADMIN_User1

Deviation Coordinator (SP_DEV_Coordinator)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

226

Instruction Status

___________________________



- For fields with multiple possible data sources, the default form will be configured to use data structures from MasterControl Data; use of external data structures will require further configuration.




Notes

227


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Click the Build Data Structure icon next to the “Products” data structure and review the default options available for the Product drop-down field in the data structure.






Complete

N/A

228

Instruction Status


If MasterControl Change Control solution package is to be used (default): - Open the Deviation.html file in any HTML editor, and search for var

CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

- Save the file.

If no Change Control Advanced system will be used: - Open the Deviation.html file in any HTML editor, and search for var

CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

- Save the file.

If no Change Control Advanced system will be used, and the reference field is editable:

- Open the Deviation.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

- Save the file.

Complete


If MasterControl Advanced Packet is to be used (default): - Open the Deviation.html file in any HTML editor, and search for var

CHANGECONTROLADVPACKET. Make sure the CHANGECONTROLADVPACKET variable is set to “MC” in the JS code.

- Save the file.

If no Advanced Packet will be used: - Open the Deviation.html file in any HTML editor and search for var

CHANGECONTROLADVPACKET. Make sure the CHANGECONTROLADVPACKET variable is set to “None” in the JS code.

- Save the file.

Complete

If CAPA Advanced (Issue Review) is to be launched from Deviation (default):


- Open the Deviation.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

229

Instruction Status

If the CAPA Essentials form is to be launched from Deviation form:



- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from Deviation form:



- Save the file.

Complete

N/A

If the Nonconformance form is to be launched from Deviation (default):

Nonconformance Type Selection (when NONCTYPE is set to ‘1’ - which represents Nonconformance form launch):

- Open the Deviation.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the Nonconformance form will *not* be launched from Deviation:

Nonconformance Type Selection (when NONCTYPE is set to ‘0’ - which represents no Nonconformance form launch, and the reference field is editable):

- Open the Deviation.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 0 in the JS code.

Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_Deviation_Source” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

230

Instruction Status

Default Custom

Incident Report

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_Deviation_PreliminaryCause” data structure and review the default options available for the Preliminary Cause drop-down field in the data structure.



Note: Make sure the “Other" option remains unchanged in the default options of the “SP_CFG_Deviation_PreliminaryCause” data structure during setup.



Complete Default Custom

Environmental Controls

Equipment Availability

Material Availability

Material Properties

Operator Error

Inadequate Procedure

Room Availability

Other

List items:




Complete

231

Notes

232






Form InfoCard Types: Deviation

Form Numbering Series: Deviation Form (Dev-xxxx)






Form Vaults: Deviation Draft

Deviation Release

Deviation Archive

Aborted Forms

Form Lifecycle: Deviation Forms

Roles

Roles: Deviation Coordinator (SP_DEV_Coordinator)









Route: Deviation

233

234

Data Structures


SP_CFG_Deviation_Source

SP_CFG_Deviation_PreliminaryCause

SP_TRANS_DEV

Template Mappings

The following template mappings are created by the installer associated with the Deviation Solution Package. Refer to the Design Specification (SP-797) for the template mapping detail:

Deviation-ExtRequest

Deviation-ChangeControlAdv

Deviation-CAPA

Deviation-Nonconformance

Deviation-IssueReview

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Deviation Solution Package. Refer to the Design Specification (SP-797) for the EventCard mapping detail:

Deviation_Agent

Deviation_Event

235

Reports


Report Names: Deviation Detail

Deviations In-Process

Deviations By Reference

Deviations By Product

Deviations 1-Year Trend

236

6. Open Items


237

eMDR

238

eMDR Installation and Configuration Checklist

1. Overview: eMDR

This document is intended to guide users through the process of installing and/or configuring the MasterControl eMDR Solution.

IMPORTANT:












239


Instruction Status




System Identified


Instruction Status




eMDR Complete

Already installed



Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed




240

Instruction Status





IMPORTANT NOTE:


Menu(s) installed:

Complete

241

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate eMDR and eMDR Followup.

In the Actions column of the eMDR and eMDR Followup rows, click the Enable Route icon (green check mark) to enable the routes.

A blue checkmark appears in the Status column for each route.

Complete

Default Custom

MDR Coordinator (SP_EMDR_Coordinator)

EMDR_User1

Extension Request Approvers (SP_EMDR_ERApprovers)

EMDR_User2

EMDR_User3


SPSUBADMIN_User1

MDR Coordinator (SP_EMDR_Coordinator)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

242

Instruction Status





Notes


Instruction Status

Update Numbering Series: The default numbering series displays in the format MFGFEI-YYYY-00001. To customize the numbering series:

- Locate the “eMDR Form” numbering series in MasterControl Portal. - Replace the “MFGFEI” with the manufacturer’s FEI/UF/Importer number (based

on the configuration on which you will configure the template), or make other appropriate changes.

- Save the updated numbering series.


Text-Section: MFGFEI-

Date-Section: YYYY-

Increment Section: 00001

Section 1:

Section 2:

Section 3:

Section 4:

Section 5:



SP-FRM- Rev

Complete

N/A

243

Instruction Status


Complete

N/A

Report Numbering Settings: The eMDR form has three report number fields. Each can be enabled or disabled depending on your requirements. To change the default settings:

- Open eMDR.html file in any HTML editor.

- Search for // Configuration variables for Mfr/UF/Importer Number in html source.

- For each configuration variable, set its value to the appropriate value: true or false. Only one of the three variables will be true. These variables are exclusively used on the form.

- Save the file.

Complete

Default Custom

MFR_Number: True

UF_Number: False

Importer_Number: False

MFR_Number: True / False

UF_Number: True / False

Importer_Number: True / False


Click the Build Data Structure icon next to the “eMDR Device Codes” data structure and review the default options available for the Device Codes drop-down field in the data structure.





Complete

Default Custom

Device 1,1449

Device 2,1450

Device 3,1451

List items:

244

Instruction Status

Click the Build Data Structure icon next to the “eMDR Evaluation Conclusions” data structure and review the default options available for the Evaluation Conclusions drop-down field in the data structure.





Complete

Default Custom

10

11

12

13

70

50

14

15

92

94

16

63

17

18

19

20

21

22

57

51

23

71

75

24

77

25

List items:

245

Instruction Status 26

27

67

61

Click the Build Data Structure icon next to the “eMDR Methods” data structure and review the default options available for the Evaluation Methods drop-down field in the data structure.





Complete

Default Custom

3261

3262

10

3263

3264

3265

3372

3266

3267

3268

3269

3270

3271

3273

3272

3274

3275

28

3276

3277

3278

3279

List items:

246


3281

3282

13

12

11

39

34

35

3283

23

3284

3285

3286

3287

3288

3289

3290

3291

27

89

3292

3293

3294

3295

3296

3297

3298

82

3299

3300

3301

3302

3303

3304

3305

247


3307

3308

3309

20

3310

36

3311

3312

3313

3314

3315

3316

3317

3319

3318

26

3320

3321

3322

3323

84

3324

3325

83

37

3326

3327

3328

3329

3330

3331

3332

3333

3341

3335

248


3337

3338

3339

95

3340

3342

3343

3344

3345

22

3346

3347

3348

3349

3350

3351

3352

3353

3354

3355

3356

3357

3358

3359

3360

3361

3362

3363

3364

3365

3366

3367

3368

3369

38

249


3371

Click the Build Data Structure icon next to the “eMDR Evaluation Results” data structure and review the default options available for the Evaluation Results drop-down field in the data structure.





Complete

Default Custom

3202

635

706

3203

3204

3205

201

628

3206

3207

658

3208

142

650

3209

663

3210

3211

135

110

646

120

197

648

List items:

250


3212

131

331

3249

3250

3251

3252

3253

3254

323

211

3255

3256

3257

3258

332

202

3259

651

3260

154

156

195

102

203

3199

618

3200

3201

144

113

3213

150

3214

610

251


3215

115

170

3216

174

180

3217

3218

3219

3220

213

3221

3222

3223

122

114

3224

196

3225

160

171

111

3226

659

3227

3228

143

3229

611

3230

3231

3232

3233

3234

3235

252


3236

121

3237

3238

104

3239

3240

3241

634

3242

193

3243

642

3244

176

3245

637

3246

3247

649

140

608

3248

Click the Build Data Structure icon next to the “eMDR Patient Codes” data structure and review the default options available for the Patient Codes drop-down field in the data structure.





Complete

253

Default Custom

Patient Code 1,1708

Patient Code 2,2229

Patient Code 3,2230

List items:

Click the Build Data Structure icon next to the “eMDR Product Codes” data structure and review the default options available for the Product Codes drop-down field in the data structure.





Complete

Default Custom

GAUGING, GAUGING, RAD, RADIOLOGICAL HEALTH, UNCLASSIFIED, 000.0000 - UNDEFINED

"PROTECTOR, DENTAL", PROTECTOR, BRW, ANESTHESIOLOGY, CLASS I, 868.5820 - DENTAL PROTECTOR.

"SET, BLOOD TRANSFUSION", SET,BRZ, GENERAL HOSPITAL, CLASS II, 880.5440 - INTRAVASCULAR ADMINISTRATION SET.

List items:

Click the Build Data Structure icon next to the “eMDR Source” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

254

"Complaint"

"eMDR"

"Incident Report"

"Other"

List items:

eMDR Follow-up settings. - No configuration setting is required.

Complete




Complete

Notes


255





Form InfoCard Types: eMDR

Form Numbering Series: eMDR Form (MFGFEI-YYYY-XXXXX)

eMDR Followup Form (MDR-F-YYYY-XXXX)






Form Vaults: eMDR Draft

eMDR Release

eMDR Archive

Aborted Forms

Form Lifecycle: eMDR Forms

Roles

Roles: MDR Coordinator (SP_EMDR_Coordinator)





Routes: eMDR

eMDR Followup

256

Data Structures

Data Structures: eMDR Product Codes

eMDR Patient Codes

eMDR Device Codes

eMDR Evaluation Conclusions

eMDR Evaluation Methods

eMDR Evaluation Results

eMDR Source

SP_TRANS_EMDR

SP_TRANS EMDRHELP

Template Mappings

The following template mapping is created by the installer associated with the eMDR Solution Package. Refer to the Design Specification (SP-798) for the template mapping detail:

eMDR-eMDRFollowup

eMDR-ExtRequest

EventCard Mappings


The following EventCard mapping is created by the installer associated with the eMDR Solution Package. Refer to the Design Specification (SP-798) for the EventCard mapping detail:

eMDR_Event

Reports


Report Names: MDR Summary

MDRs by Product

MDRs by Outcome

MDRs Awaiting Acknowledgments

MDR Time to Report

MDRs 1-Year Trend

257

6. Open Items


258

Equipment Calibration

259

Equipment Calibration Installation and Configuration Checklist

1. Overview: Equipment Calibration

This document is intended to guide users through the process of installing and/or configuring the MasterControl Equipment Calibration Solution.

IMPORTANT:












260


Instruction Status




System Identified


Instruction Status




Equipment Calibration Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed





Complete

261

Instruction Status

Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Calibration Work Order.

In the Actions column of the Calibration Work Order row, click the Enable Route icon (green check mark) to enable the route.


Default Custom

Calibration Manager (SP_CAL_Manager)

CAL_USER1

Calibration Team (SP_CAL_Team)

CAL_USER2

CAL_USER3


SPSUBADMIN_User1

Calibration Manager (SP_CAL_Manager)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

Create a single scheduled forms task for the form. This is required in order to be able to configure scheduled form task reports, which are not created by the installer.

Complete

262

Instruction Status

Create the following standard report. Refer to the Design Specification (SP-799) for detailed report specifications.

Calibration Schedule





Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

The GracePeriod variable determines the number of days that a task is generated before its due date. The default value is 14 days.

To change the default setting, open the Calibration.html file in any HTML editor and search for the section var Grace_Period from code. Set the Graceperiod variable to the desired value and save your changes.

GracePeriod (days):

Complete

Used Defaults

263

Instruction Status

To CalibrationScheduleType variable determines the next due date of a task. If the variable is set to “fixed_schedule,” then the next task is scheduled based on the prior creation date and not on the actual completion date of the task. If the variable is set to “completion_based,” then the next task is scheduled based on the actual completion date of the prior task.

To change the default setting, open the Calibration.html file in any HTML editor and search for the section var CalibrationScheduleType from code. Set the CalibrationScheduleType variable to the desired value and save your changes.

Calibration Schedule Type (circle one):

fixed_schedule

completion_based (default)

Complete

Used Defaults




Complete


Click the Build Data Structure icon next to the “Calibration Methods” data structure and review the default options available for the Calibration Methods drop-down field in the data structure.





Complete

264

Default Custom

m1, c1, c1, t1, et1, et2, et3, et4, et5, sd1, sd2, sd3, sd4, sd5, param1, setpoint1, adj1, fail1, param2, setpoint2, adj2, fail2, param3, setpoint3, adj3, fail3, param4, setpoint4, adj4, fail4, param5, setpoint5, adj5, fail5

List items:

Notes

265




Note: There is one more numbering series created by the installer i.e. “CAL-MTH-xxxxx” that will attach with Row_ID column of the Calibration Methods Data Structure.

Template InfoCard Type: Manufacturing Operations


Form InfoCard Types: Calibration Work Order

Form Numbering Series: Calibration Form (CAL-xxxx)






Form Vaults: Calibration Draft

Calibration Release

Calibration Archive

Aborted Forms

Form Lifecycle: Calibration Forms

Roles

Roles: Calibration Manager (SP_CAL_Manager)





Route: Calibration Work Order

266

Data Structures

Data Structures: Calibration Methods

Equipment Master

SP_TRANS_CAL

Template Mappings


EventCard Mappings


Reports


Report Names: Calibration History

Current Calibration Tasks

Calibration Tasks Past Due

Failure Incidence By Equipment

Failure Incidence By Task

Failure Incidence 1-Year Trend

Out-of-Tolerance Incidence By Equipment

Out-of-Tolerance Incidence By Task

Out of Tolerance Incidence 1-Year Trend

267

6. Open Items


268

Equipment Maintenance

269

Equipment Maintenance Installation and Configuration Checklist

1. Overview: Equipment Maintenance

This document is intended to guide users through the process of installing and/or configuring the MasterControl Equipment Maintenance Solution.

IMPORTANT:












270


Instruction Status




System Identified


Instruction Status




Equipment Maintenance Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed




271

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Maintenance Work Request and Preventive Maintenance.

In the Actions column of the Maintenance Work Request and Preventive Maintenance rows, click the Enable Route icon (green check mark) to enable the routes.


Complete

Default Custom

Maintenance Manager (SP_MAINT_Manager)

MAINT_USER1

Maintenance Team (SP_MAINT_Team)

MAINT_USER2

MAINT_USER3

MAINT_USER4

Maintenance Work Requester (SP_MAINT_WorkRequester)

MAINT_USER5

MAINT_USER6

MAINT_USER7

Maintenance Manager (SP_MAINT_Manager)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

272

Instruction Status


SPSUBADMIN_User1


___________________________

___________________________

___________________________

Create a single scheduled forms task for the form. This is required in order to be able to configure scheduled form task reports, which are not created by the installer.

Create the following standard report. Refer to the Design Specification (SP-800) for detailed report specifications.

Maintenance Schedule

Complete





Notes

273


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

The GracePeriod variable determines the number of days that a task is generated before its due date. The default value is 14 days. To change this configuration setting:

To change the default setting, open the Maintenance.html file in any HTML editor and search for the section var DEFAULTGRACEPERIOD from code. Set the Graceperiod variable to the desired value and save your changes.

GracePeriod (days):

Complete

Used Defaults

The MaintenanceScheduleType variable determines the next due date of a task. If the variable is set to “fixed_schedule”, then the next task is scheduled based on the prior creation date and not on the actual completion date of the task. If the variable is set to “completion_based”, then the next task is scheduled based on the actual completion date of the prior task.

To change the default setting, open the Maintenance.html file in any HTML editor and search for the section var MAINTSCHEDULETYPE from code. Set the MaintenanceScheduleType variable to the desired value and save your changes.

Maintenance Schedule Type (circle one):

“completion_based” (default)

“fixed_schedule”

Complete

Used Defaults

274

Instruction Status




Complete


Click the Build Data Structure icon next to the “Maintenance Methods” data structure and review the default options available for the Maintenance Methods drop-down field in the data structure.





Complete

275

Default Custom

Method Title 1,TaskInstructions 1,Qneeded 1,Pnum 1,Description 1,Qneeded 2,Pnum 2,Description 2,Qneeded 3,Pnum 3,Description 3,Qneeded 4,Pnum 4,Description 4,Qneeded 5,Pnum 5,Description 5,Qneeded 6,Pnum 6,Description 6,Qneeded 7,Pnum 7,Description 7,Qneeded 8,Pnum8,Description 8,Qneeded 9,Pnum 9,Description 9,Qneeded 10,Pnum 10,Description 10,Equation Type1,Equation Type2,Equation Type3,Equation Type4,Equation Type5

Method Title 11,TaskInstructions 11,Qneeded 11,Pnum 11,Description 11,Qneeded 22,Pnum 22,Description 22,Qneeded 33,Pnum 33,Description 33,Qneeded 44,Pnum 44,Description 44,Qneeded 55,Pnum 55,Description 55,Qneeded 66,Pnum 66,Description 66,Qneeded 77,Pnum 77,Description 77,Qneeded 88,Pnum88,Description 88,Qneeded 99,Pnum 99,Description 99,Qneeded 101,Pnum 101,Description 101,Equation Type11,Equation Type22,Equation Type33,Equation Type44,Equation Type55

List items:

276

Notes

277




Note: There is one more numbering series created by the installer i.e. “MAINT-MTH-xxxxx” that will attach with Row_ID column of the Maintenance Methods Data Structure.

Template InfoCard Type: Manufacturing Operations


Form InfoCard Types: Maintenance Work Order

Form Numbering Series: Maintenance Form (WO-xxxx)






Form Vaults: Maintenance Draft

Maintenance Release

Maintenance Archive

Aborted Forms

Form Lifecycle: Maintenance Forms

Roles

Roles: Maintenance Manager (SP_MAINT_Manager)






Routes: Maintenance Work Request

Preventive Maintenance

278

279

Data Structures

Data Structures: Maintenance Methods

Equipment Master

SP_TRANS_MAINT

Template Mappings


EventCard Mappings


Reports


Report Names: Maintenance History

Current Maintenance Tasks

Maintenance Tasks Past Due

Corrective Maintenance by Cause

280

6. Open Items


281

Extension Request

Extension Request Installation and Configuration Checklist

1. Overview: Extension Request

This document is intended to guide users through the process of installing and/or configuring the MasterControl Extension Request Solution.

IMPORTANT:


282











283


Instruction Status




System Identified

284


Instruction Status




Extension Request Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_QE_Extension_Request_Menu.xml. This will create a quality event menu under a Quality Events main menu item for this solution.

IMPORTANT NOTE:


Menu(s) installed:

Complete

285

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Extension Request.

In the Actions column of the Extension Request row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Extension Request Viewers (SP_ER_ExtReqViewers)

ER_USER1

ER_USER2


SPSUBADMIN_User1

Extension Request Viewers (SP_ER_ExtReqViewers)

______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

Note: All users, who need to view the launched Extension Requests, must be added to "Extension Request Viewers" role.



286

Instruction Status



Notes


Instruction Status



SP-FRM- Rev


Complete

N/A

287

Notes

288






Form InfoCard Types: Extension Request

Form Numbering Series: Extension Request Form (EXT-xxxxx)






Form Vaults: Extension Request Draft

Extension Request Release

Extension Request Archive

Aborted Forms

Form Lifecycle: Extension Request Forms

Roles

Roles: Extension Request Viewers (SP_ER_ExtReqViewers)




Route: Extension Request

289

Data Structures

Data Structures: SP_TRANS_EXT

Template Mappings


EventCard Mappings


Reports


Report Names: Extension Requests in Process

Extension Requests by Source

290

6. Open Items


291

HR/Finance

292

HR/Finance Installation and Configuration Checklist

1. Overview: HR/Finance

This document is intended to guide through the process of installing and/or configuring the MasterControl HR/Finance Solution.

IMPORTANT:












293


Instruction Status




System Identified


Instruction Status




HR-Finance Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed





Complete

294

Instruction Status

Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Employee Entry Checklist, Employee Exit Checklist, Purchase Order, and Vacation Request.

In the Actions column of the Employee Entry Checklist, Employee Exit Checklist, Purchase Order, and Vacation Request rows, click the Enable Route icon (green check mark) to enable the routes.

A blue checkmark appears in the Status columns.

Default Custom

HR Group (SP_HRF_HRGroup)

HRF_USER1

HRF_USER2

Finance Group (SP_HRF_FinanceGroup)

HRF_USER3

HRF_USER4

Managers (SP_HRF_Managers)

HRF_USER5

HRF_USER6

HR Group (SP_HRF_HRGroup)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

295

Instruction Status

PTO Initiators (SP_HRF_PTOInitiators)

HRF_USER7 (The HRF_USER5 is selected as it’s Supervisor by the installer)


PO Initiators (SP_HRF_POInitiators)



Help Desk Group (SP_HRF_HelpDeskGroup)

HRF_USER11

HRF_USER12

Admin Group (SP_HRF_AdminGroup)

HRF_USER13

HRF_USER14


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


If configuration is required, then sections 4.1 Post-Installation Configuration – Vacation Request, 4.2 Post-Installation Configuration – Employee Entry Checklist, 4.3 Post-Installation Configuration – Employee Exit Checklist and 4.4 Post-Installation Configuration – Purchase Order, need to be completed.



Notes

296

Instruction Status

4.1. Post-Installation Configuration – Vacation Request

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Open PTO.html file in any HTML editor.

Search for T2 Type of Time Off X, where X=1 to 10, in html source. Review the options for all ten Type of Time-off drop-down fields. Static drop-down options can be changed in the field’s option attribute, if desired.

Complete

297

Default Custom

(blank)

Floating Holiday

PTO - Vacation

PTO - Personal Time

PTO - Sick

Bereavement

Military Leave

Time Off Without Pay (not FMLA)

Family Medical Leave Act

Jury Duty/Witness Duty

List items:

Check in the template InfoCard you previously checked out and load the modified HTML file, and then click on the Form Fields tab. Save the template and quick approve it with an effective date of today.


Complete

Notes

4.2. Post-Installation Configuration – Employee Entry Checklist

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

298

Instruction Status

Open EmployeeEntry_Checklist.html file in any HTML editor.

Search for T2 Position Type in html source.

Review the drop-down options on the Position Type field. Static drop-down options can be changed in the field’s option attribute, if desired.

Complete

Default Custom

(blank)

Permanent Full-Time

Permanent Part-Time

Temporary

Contractor

List items:




Complete

Notes

299

4.3. Post-Installation Configuration – Employee Exit Checklist

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Open EmployeeExit_Checklist.html file in any HTML editor.

Search for T2 Position Type in html source.

Review the drop-down options on the Position Type field. Static drop-down options can be changed in the field’s option attribute, if desired.

Complete

Default Custom

(blank)

Permanent Full-Time

Permanent Part-Time

Temporary

Contractor

List items:




Complete

300

Notes

4.4. Post-Installation Configuration – Purchase Order

Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

Click the Build Data Structure icon next to the “SP_CFG_HRF_Project_Number” data structure and review the default options available for the Project Number drop-down field in the data structure.





Complete

301

Default Custom

(blank)

Project Number 1

Project Number 2

Project Number 3

List items:

Search for T2 Ship Via in HTML source.

Review the drop-down options on the Ship Via field. Static drop-down options can be changed in the field’s option attribute, if desired.

Complete

Default Custom

(blank)

Postal Service

DHL

FedEx

UPS

Any

List items:

Search for T2 Shipping Priority in HTML source.

Review the drop-down options on the Shipping Priority field. Static drop-down options can be changed in the field’s option attribute, if desired.

Complete

302

Default Custom

(blank)

Standard

Priority

Express

Overnight

List items:




Complete

Notes

303




Template InfoCard Type: HR and Finance


Form InfoCard Types: PTO

Employee Entry

Employee Exit

PO

Form Numbering Series: PTO Form (PTO-xxxx)

Employee Entry Form (EMPE-xxxx)

Employee Exit Form (EMPX-xxxx)

PO Form (PO-xxxx)






Form Vaults: HR Draft

HR Release

HR Archive

Finance Draft

Finance Release

Finance Archive

Aborted Forms

Form Lifecycles: HR Forms

Finance Forms

304

Roles

Roles: HR Group (SP_HRF_HRGroup)










SP-FRM-0055

SP-FRM-0056

SP-FRM-0057

Routes: Vacation Request

Employee Entry Checklist

Employee Exit Checklist

Purchase Order

Data Structures


SP_CFG_HRF_Project_Number

SP_TRANS_HRF_EMPE

SP_TRANS_HRF_EMPX

SP_TRANS_HRF_PO

SP_TRANS_HRF_PTO

Template Mappings


305

EventCard Mappings


Reports

Installer has created the default datasets named as SP-FRM-0054, SP-FRM-0055, SP-FRM-0056, and SP-FRM-0057, and the following standard reports. Refer to the Design Specification (SP-802) for detailed report specifications.

Vacation Request Form – Reports Names: Active Vacation Requests

Vacation Request by User

Vacation Request by Manager

Employee Entry Checklist Form – Reports Names: Active Entry Checklists

Entry Checklists by Department

Employee Exit Checklist Form – Reports Names: Active Exit Checklists

Exit Checklists by Department

Purchase Order Form – Reports Names: Active Purchase Orders

Purchase Orders by User

Purchase Orders by Department

Purchase Orders by Project

306

6. Open Items


307

Incident Reporting

308

Incident Reporting Installation and Configuration Checklist

1. Overview: Incident Reporting

This document is intended to guide users through the process of installing and/or configuring the MasterControl Incident Reporting Solution.

IMPORTANT:












309


Instruction Status




System Identified


Instruction Status




Incident Reporting Complete

Already installed



Complete

Already installed



CAPA Essentials

Complete

Already installed

Not Used



CAPA Advanced

Complete

Already installed

Not Used

310

Instruction Status


If MasterControl Customer Complaint Essentials solution package is to be used, then select the following SP from the list:


Complete

Already installed

Not Used


If MasterControl Customer Complaint Advanced solution package is to be used, then select the following SP from the list:

Customer Complaint Advanced

Complete

Already installed

Not Used



eMDR

Complete

Already installed

Not Used


If MasterControl Out-of-Specification (OOS) solution package is to be used, then select the following SP from the list:


Complete

Already installed

Not Used



Nonconformance

Complete

Already installed

Not Used

311

Instruction Status


If MasterControl Deviation solution package is to be used, then select the following SP from the list:

Deviation

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed





Install the SP_SA_Incident Report_Menu.xml. This will create a standalone menu for this solution.


IMPORTANT NOTE:


Menu(s) installed:

Complete

312

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Incident Report.

In the Actions column of the Incident Report row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Incident Rpt Coordinator (SP_INC_Coordinator)

IR_User1

Incident Rpt Initiators (SP_INC_Initiators)

IR_User2

IR_User3

Extension Request Approvers (SP_INC_ERApprovers)

IR_User4

IR_User5

Incident Rpt Coordinator (SP_INC_Coordinator)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

313

Instruction Status


SPSUBADMIN_User1

______________________________


___________________________

___________________________

___________________________





Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

314

Instruction Status


Click the Build Data Structure icon next to the “SP_CFG_INC_IssueType” data structure and review the default options available for the Issue Type drop-down field in the data structure.





Complete

Default Custom

General

Legal

Safety

Quality

List items:

Click the Build Data Structure icon next to the “SP_CFG_INC_Disposition” data structure and review the default options available for the Disposition drop-down field in the data structure.



Note: Make sure the “Escalated" option remains unchanged in the default options of the “SP_CFG_INC_Disposition” data structure during setup.



Complete

315

Instruction Status

Default Custom

Escalated

Assigned

Not Actionable

Invalid

List items:

If CAPA Advanced (Issue Review) is to be launched from Incident Reporting (default):


- Open the Incident_Reporting.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from Incident Reporting form:



- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from Incident Reporting:



- Save the file.

Complete

N/A

If the Customer Complaint Essentials form is to be launched from the Incident Reporting form (default):

Complaint Type Selection (when COMPLAINTTYPE is set to ‘1' - which represents Customer Complaint Essentials form launch):

- Open the Incident_Reporting.html file in any HTML editor, and search for var COMPLAINTTYPE. Make sure the COMPLAINTTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the Customer Complaint Advanced form is to be launched from the Incident Reporting form:

Complete

316

Instruction Status

Complaint Type Selection (when COMPLAINTTYPE is set to ‘2' - which represents Customer Complaint Advanced form launch):


- Save the file.

N/A

If the Customer Complaint form will *not* be launched from the Incident Reporting form:

Complaint Type Selection (when COMPLAINTTYPE is set to ‘0' - which represents no Customer Complaint form launch, and the reference field is editable):


- Save the file.

Complete

N/A

If the OOS form is to be launched from the Incident Reporting form (default):

OOS Type Selection (when OOSTYPE is set to ‘1' - which represents OOS form launch):

- Open the Incident_Reporting.html file in any HTML editor, and search for var OOSTYPE. Make sure the OOSTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the OOS form will *not* be launched from the Incident Reporting form:

OOS Type Selection (when OOSTYPE is set to ‘0' - which represents no OOS form launch, and the reference field is editable):

- Open the Incident_Reporting.html file in any HTML editor, and search for var OOSTYPE. Make sure the OOSTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

If the Nonconformance form is to be launched from the Incident Reporting form (default):

Nonconformance Type Selection (when NONCTYPE is set to ‘1' - which represents Nonconformance form launch):

- Open the Incident_Reporting.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

317

If the Nonconformance form will *not* be launched from the Incident Reporting form:

Nonconformance Type Selection (when NONCTYPE is set to ‘0' - which represents no Nonconformance form launch, and the reference field is editable):

- Open the Incident_Reporting.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

If the eMDR form is to be launched from the Incident Reporting form (default):

eMDR Type Selection (when EMDRTYPE is set to ‘1' - which represents eMDR form launch):

- Open the Incident_Reporting.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the eMDR form will *not* be launched from the Incident Reporting form:

eMDR Type Selection (when EMDRTYPE is set to ‘0' - which represents no eMDR form launch, and the reference field is editable):

- Open the Incident_Reporting.html file in any HTML editor, and search for var EMDRTYPE. Make sure the EMDRTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

If the Deviation form is to be launched from the Incident Reporting form (default):

Deviation Type Selection (when DEVTYPE is set to ‘1' - which represents Deviation form launch):

- Open the Incident_Reporting.html file in any HTML editor, and search for var DEVTYPE. Make sure the DEVTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the Deviation form will *not* be launched from the Incident Reporting form:

Deviation Type Selection (when DEVTYPE is set to ‘0' - which represents no Deviation form launch, and the reference field is editable):

- Open the Incident_Reporting.html file in any HTML editor, and search for var DEVTYPE. Make sure the DEVTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

318


Save the template and quick approve it with an effective date of today. Mark the route available by clicking the “Make Route Available” icon next to the route and the solution package is ready for use.

Complete

Notes

319






Form InfoCard Types: Incident Report

Form Numbering Series: Incident Report Form (IR-xxxx)






Form Vaults: Incident Report Draft

Incident Report Release

Incident Report Archive

Aborted Forms

Form Lifecycle: Incident Report Forms

Roles

Roles: Incident Rpt Coordinator (SP_INC_Coordinator)






Route: Incident Report

320

Data Structures


SP_CFG_INC_IssueType

SP_CFG_INC_Disposition

SP_CFG_INC_Source

SP_TRANS_IR

Template Mappings

The following template mappings are created by the installer associated with the Incident Reporting Solution Package. Refer to the Design Specification (SP-803) for the template mapping detail:

IncidentReporting-ExtRequest

IncidentReporting-CAPA

IncidentReporting-Complaint

IncidentReporting-ComplaintAdv

IncidentReporting-eMDR

IncidentReporting-IssueReview

IncidentReporting-OOS

IncidentReporting-Nonconformance

IncidentReporting-Deviation

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Incident Reporting Solution Package. Refer to the Design Specification (SP-803) for the EventCard mapping detail:

IncidentReporting_Agent

IncidentReporting_Event

321

Reports


Report Names: Active Incident Reports

Incident Reports by Issue Type

Incident Reports by Department

322

6. Open Items


323

Meeting Notes

324

Meeting Notes Installation and Configuration Checklist

1. Overview: Meeting Notes

This document is intended to guide through the process of installing and/or configuring the MasterControl Meeting Notes Solution.

IMPORTANT:












325


Instruction Status




System Identified


Instruction Status




Meeting Notes Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed





Install Test Users:



Complete

326

Instruction Status




Enable the route:

Go to Process > Routes. In the Route Name column, locate Meeting Notes and Meeting Notes AI.

In the Actions column of the Meeting Notes and Meeting Notes AI rows, click the Enable Route icon (green check mark) to enable the routes.


Default Custom

Meeting Facilitators (SP_MEET_Facilitators)

MEET_User1

MEET_User2

Meeting Participants (SP_MEET_Participants)

MEET_User3

MEET_User4

MEET_User5

MEET_User6


SPSUBADMIN_User1

Meeting Facilitators (SP_MEET_Facilitators)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________


If configuration is required, then sections 4.1. Post-Installation Configuration – Action Item and 4.2. Post-Installation Configuration – Meeting Notes need to be completed.



327

Instruction Status

Notes

4.1. Post-Installation Configuration – Action Item

Instruction Status



SP-FRM- Rev


Complete

N/A

328

Notes

329

4.2. Post-Installation Configuration – Meeting Notes

Instruction Status



SP-FRM- Rev


Complete

N/A


Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_Meeting_TentativeLocation” data structure and review the default options available for the Tentative Location drop-down field in the data structure.





Complete

Default Custom

Conference Room 1

Conference Room 2

Conference Room 3

List items:

Action Items settings. - No configuration setting is required.

Complete

330

Notes

331




Template InfoCard Type: General Productivity


Form InfoCard Types: Action Items

Meeting Notes

Form Numbering Series: Action Item Form (AI-xxxx)

Meeting Notes Form (Meeting-xxxx)






Form Vaults: Action Item Draft

Action Item Release

Action Item Archive

Meeting Notes Draft

Meeting Notes Release

Meeting Notes Archive

Aborted Forms

Form Lifecycles: Action Item Forms

Meeting Notes Forms

332

Roles

Roles: Meeting Facilitators (SP_MEET_Facilitators)





SP-FRM-0053

Routes: Meeting Notes AI

Meeting Notes

Data Structures

Data Structures: SP_CFG_Meeting_Source

SP_CFG_Meeting_TentativeLocation

SP_CFG_MeetingAI_Source

SP_TRANS_MEET

SP_TRANS_MEET_ACT

Template Mappings

Template Mappings: MeetingNotes-ActionItem

EventCard Mappings


333

Reports

Installer has created the default datasets named as SP-FRM-0052 and SP-FRM-0053 for the following standard reports. Refer to the Design Specification (SP-804) for detailed report specifications.

Meeting Notes Form – Reports Names Meetings In Process

All Meeting Notes

Meetings by Facilitator

Action Item Form – Reports Names: Action Items In Process

All Action Items

Action Items Past Due

334

6. Open Items


335

Nonconformance

336

Nonconformance Installation and Configuration Checklist

1. Overview: Nonconformance

This document is intended to guide users through the process of installing and/or configuring the MasterControl Nonconformance Solution.

IMPORTANT:












337


Instruction Status




System Identified


Instruction Status




Nonconformance Complete

Already installed




Complete

Already installed



CAPA Essentials

Complete

Already installed

Not Used


Complete

338

Instruction Status


CAPA Advanced

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Menu(s) installed:

Complete

339

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Nonconformance.

In the Actions column of the Nonconformance row, click the Enable Route icon (green check mark) to enable the route.


Complete

340

Default Custom

Nonconformance Coordinator (SP_NONC_Coordinator)

NONC_USER1

Nonconformance Users (SP_NONC_Users)

NONC_USER2

NONC_USER3

Task Owners (SP_NONC_TaskOwners)

NONC_USER4

NONC_USER5

Extension Request Approvers (SP_NONC_ERApprovers)

NONC_USER6

NONC_USER7

Decision Makers (SP_NONC_DecisionMakers)

NONC_USER8

NONC_USER9


SPSUBADMIN_User1

Nonconformance Coordinator (SP_NONC_Coordinator)

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

341



- For fields with multiple possible data sources, the default form will be configured to use data structures from MasterControl Data; use of external data structures or MasterControl Supplier (if applicable) will require further configuration.




Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

342

Instruction Status

Click the Build Data Structure icon next to the “Suppliers” data structure and review the default options available for the Product drop-down field in the data structure.






Complete

343

Instruction Status

If CAPA Advanced (Issue Review) is to be launched from Nonconformance (default):


- Open the Nonconformance.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from Nonconformance form:



- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from Nonconformance form:



- Save the file.

Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_NCMR_Source” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

344

Default Custom

Audit

Deviation

Incident Report


Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Quarn_Location” data structure and review the default options available for the Quarantine Location drop-down field in the data structure.





Complete

Default Custom

Cage 1

Cage 2

Cage 3

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Machine_Ref” data structure and review the default options available for the Machine/Process Reference drop-down field in the data structure.





Complete

345

Default Custom

EQ-0001

EQ-0002

EQ-0003

Proc-0001

Proc-0002

Proc-0003

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Shift_And_Time” data structure and review the default options available for the Shift/Time drop-down field in the data structure.





Complete

Default Custom

Shift A Morning

Shift A Evening

Shift B Morning

Shift B Evening

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Line_Number” data structure and review the default options available for the Line Number drop-down field in the data structure.





Complete

346

Default Custom

Line-0001

Line-0002

Line-0003

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Material_Grade” data structure and review the default options available for the Grade drop-down field in the data structure.





Complete

Default Custom

Grade A

Grade B

Grade C

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Veri_Method” data structure and review the default options available for the Verification Method drop-down field in the data structure.





Complete

347

Default Custom

Method-001

Method-002

Method-003

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_New_Grade” data structure and review the default options available for the New Grade drop-down field in the data structure.





Complete

Default Custom

Grade A

Grade B

Grade C

List items:

Click the Build Data Structure icon next to the “SP_CFG_NCMR_Disp_Method” data structure and review the default options available for the Disposition Method drop-down field in the data structure.





Complete

348

Default Custom

Method-A

Method-B

Method-C

List items:


Save the template and quick approve it with an effective date of today. Mark the route available by clicking the “Make Route Available” icon next to the route. The solution package is ready for use.

Complete

349

Notes

350






Form InfoCard Types: Nonconformance

Form Numbering Series: Nonconformance Form (NCMR-xxxx)






Form Vaults: Nonconformance Draft

Nonconformance Release

Nonconformance Archive

Aborted Forms

Form Lifecycle: Nonconformance Forms

Roles

Roles: Nonconformance Coordinator (SP_NONC_Coordinator)








Route: Nonconformance

351

Data Structures


Suppliers

SP_CFG_NCMR_Source

SP_CFG_NCMR_Quarn_Location

SP_CFG_NCMR_Machine_Ref

SP_CFG_NCMR_Shift_And_Time

SP_CFG_NCMR_Line_Number

SP_CFG_NCMR_Material_Grade

SP_CFG_NCMR_Veri_Method

SP_CFG_NCMR_New_Grade

SP_CFG_NCMR_Disp_Method

SP_TRANS_NCMR

Template Mappings

The following template mappings are created by the installer associated with the Nonconformance Solution Package. Refer to the Design Specification (SP-805) for the template mapping detail:

Nonconformance-ActionItem

Nonconformance-CAPA

Nonconformance-ExtRequest

Nonconformance-IssueReview

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Nonconformance Solution Package. Refer to the Design Specification (SP-805) for the EventCard mapping detail:

Nonconformance_Agent

Nonconformance_Event

352

Reports


Report Names: Nonconformance Summary

Nonconformance In-Process

Nonconformances By Material

Nonconformances by Disposition

Nonconformances 1-Year Trend

353

6. Open Items


354

Out-of-Specification (OOS)

355

Out-of-Specification Installation and Configuration Checklist

1. Overview: OOS

This document is intended to guide users through the process of installing and/or configuring the MasterControl Out-of-Specification (OOS) Solution.

IMPORTANT:












356


Instruction Status




System Identified


Instruction Status





Complete

Already installed



Complete

Already installed



CAPA Essentials

Complete

Already installed

Not Used



CAPA Advanced

Complete

Already installed

Not Used


Complete

Already installed

357

Instruction Status


Nonconformance

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Menu(s) installed:

Complete

358

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate OOS.

In the Actions column of the OOS row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

OOS Lab Manager (SP_OOS_LabManager)

OOS_User1

OOS QA (SP_OOS_QA)

OOS_User2

OOS_User3

OOS Users (SP_OOS_Users)

OOS Lab Manager (SP_OOS_LabManager)

______________________________

______________________________

OOS QA (SP_OOS_QA)

______________________________

______________________________

______________________________


______________________________

359

Instruction Status

OOS_User4

OOS_User5

OOS Analyst (SP_OOS_Analyst)

OOS_User6

OOS_User7

Extension Request Approvers (SP_OOS_ERApprovers)

OOS_User8

OOS_User9


SPSUBADMIN_User1

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________







360

Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

361

Instruction Status

Click the Build Data Structure icon next to the “Equipment Master” data structure and review the default options available for the Product drop-down field in the data structure.






Complete

Click the Build Data Structure icon next to the “SP_CFG_OOS_Specification_ID” data structure and review the default options available for the Product drop-down field in the data structure.





Complete

362

Default Custom

(blank)

Spec-0001,Specification One

Spec-0002,Specification Two

Spec-0003,Specification Three

Describe or list items:

Click the Build Data Structure icon next to the “SP_CFG_OOS_Test_Methods” data structure and review the default options available for the Product drop-down field in the data structure.





Complete

Default Custom

(blank)

Method 1,Method One Title

Method 2,Method Two Title

Method 3,Method Three Title

External Data Structure

Static List

Describe or list items:

Search for T4 Additional Data Generated in html source.

Review the multi-selection list options on the Additional Data Generated field. These options can be changed in the field’s option attribute, if desired.

Complete

363

Default Custom

Retest

Resample

Rework

Reprocess

Other

None

List items:

If CAPA Advanced (Issue Review) is to be launched from OOS (default):

CAPA Type Selection (when CAPATYPE is set to ‘1’ - which represents CAPA Advanced (Issue Review) form launch):

- Open the OOS.html file in any HTML editor, and search for var CAPATYPE. Make sure the CAPATYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the CAPA Essentials form is to be launched from OOS form:

CAPA Type Selection (when CAPATYPE is set to ‘2’ - which represents CAPA Essentials form launch):


- Save the file.

Complete

N/A

If the CAPA form will *not* be launched from OOS form:



- Save the file.

Complete

N/A

If the Nonconformance form is to be launched from OOS (default):

Nonconformance Type Selection (when NONCTYPE is set to ‘1’ - which represents Nonconformance form launch):

- Open the OOS.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

If the Nonconformance form will *not* be launched from OOS:

364

Nonconformance Type Selection (when NONCTYPE is set to ‘0’ - which represents no Nonconformance form launch, and the reference field is editable):

- Open the OOS.html file in any HTML editor, and search for var NONCTYPE. Make sure the NONCTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_OOS_Source” data structure and review the default options available for the Source drop-down field in the data structure.





Complete

Default Custom

Incident Report

Other

List items:

Click the Build Data Structure icon next to the “SP_CFG_OOS_Analysis_Type” data structure and review the default options available for the Analysis Type drop-down field in the data structure.





Complete

Default Custom

365

Content Uniformity

Assay

Dissolution

Identity

Physical Properties

Degradant/Impurity

Microbial

Bioavailability

List items:

Click the Build Data Structure icon next to the “SP_CFG_OOS_Test_Type” data structure and review the default options available for the Test Type drop-down field in the data structure.






Raw Material

In-Process

Finished Product

Stability

Water

Clinical

List items:

Click the Build Data Structure icon next to the “SP_CFG_OOS_Laboratory” data structure and review the default options available for the Laboratory drop-down field in the data structure.





Complete

Default Custom

366

QC-01

QC-02

QC-03

RD-01

RD-02

RD-03

List items:

Click the Build Data Structure icon next to the “SP_CFG_OOS_Error_Cause” data structure and review the default options available for the Error Cause drop-down field in the data structure.






Test Method Deficiency

Training Deficiency

Equipment Function

Calculation Error

Processing Error

Inconclusive

Other

List items:




Complete

367

Notes

368






Form InfoCard Types: OOS

Form Numbering Series: OOS Form (OOS-xxxx)






Form Vaults: OOS Draft

OOS Release

OOS Archive

Aborted Forms

Form Lifecycle: OOS Forms

Roles

Roles: OOS Lab Manager (SP_OOS_LabManager)

OOS QA (SP_OOS_QA)







Route: OOS

369

Data Structures

Data Structures: Equipment Master

Products

SP_CFG_OOS_Analysis_Type

SP_CFG_OOS_Test_Type

SP_CFG_OOS_Laboratory

SP_CFG_OOS_Error_Cause

SP_TRANS_OOS

SP_CFG_OOS_Source

SP_CFG_OOS_Specification_ID

SP_CFG_OOS_Test_Methods

Template Mappings

The following template mappings are created by the installer associated with the OOS Solution Package. Refer to the Design Specification (SP-806) for the template mapping detail:

OOS-ExtRequest

OOS-CAPA

OOS-Nonconformance

OOS-IssueReview

EventCard Mappings


The following EventCard mapping is created by the installer associated with the OOS Solution Package. Refer to the Design Specification (SP-806) for the EventCard mapping detail:

OOS_Agent

OOS_Event

370

Reports


Report Names: Active OOS

OOS by Product

OOS by Analysis Type

OOS by Test Type

OOS by Error Cause

371

6. Open Items


372

Risk Analysis

373

Risk Analysis Installation and Configuration Checklist

1. Overview: Risk Analysis

This document is intended to guide users through the process of installing and/or configuring the MasterControl Risk Analysis Solution.

IMPORTANT:












374


Instruction Status




System Identified


Instruction Status




Risk Analysis Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed




375

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Risk Analysis.

In the Actions column of the Risk Analysis row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Risk Analysis Initiators (SP_RISK_Initiators)

RA_USER1

RA_USER2

RA_USER3

Risk Analysis SME (SP_RISK_SME)

RA_USER4


SPSUBADMIN_User1

Risk Analysis Initiators (SP_RISK_Initiators)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

376

Instruction Status





Notes


Instruction Status

Locate the template created by the installer (numbering series RA-FRM-xxxx).


SP-FRM- Rev


Complete

N/A


Complete

N/A

377

Instruction Status


Click the Build Data Structure icon next to the “SP_CFG_RA_Source” data structure and review the default options available for the Source drop-down field in the data structure.



Note: Make sure the “Other" option remains unchanged in the default options of the “SP_CFG_RA_Source” data structure during setup.



Complete

Default Custom

Audit Finding

CAPA

Change Control

Customer Complaint

Field Report

Design Study

Deviation

Nonconformance

Other

List items:

Notes

378






Form InfoCard Types: Risk Analysis

Form Numbering Series: Risk Analysis Form (RA-xxxx)






Form Vaults: Risk Analysis Draft

Risk Analysis Release

Risk Analysis Archive

Aborted Forms

Form Lifecycle: Risk Analysis Forms

Roles

Roles: Risk Analysis Initiators (SP_RISK_Initiators)





Route: Risk Analysis

379

Data Structures

Data Structures: SP_CFG_RA_Source

SP_TRANS_RA

Template Mappings


EventCard Mappings


Reports


Report Names: Active Analyses

Risk Analyses By Source

380

6. Open Items


381

Supplier Corrective Action

382

Supplier Corrective Action Installation and Configuration Checklist

1. Overview: Supplier Corrective Action

This document is intended to guide users through the process of installing and/or configuring the MasterControl Supplier Corrective Action Solution.

IMPORTANT:












383


Instruction Status




System Identified


Instruction Status




SCAR Complete

Already installed



Complete

Already installed


Template Mappings

Complete


Data Structures

Complete

Already installed




384

Instruction Status





IMPORTANT NOTE:


Menu(s) installed:

Complete


Install Test Users:



Go to Portal > User Management > Roles then click the edit icon next to each role and in edit security role window make sure that the test users have been associated with their appropriate roles as indicated below in the default column.

Complete

385

Instruction Status



Enable the route:

Go to Process > Routes. In the Route Name column, locate SCAR.

In the Actions column of the SCAR row, click the Enable Route icon (green check mark) to enable the route.


Default Custom

Supplier Management (SP_SCAR_Management )

SCAR_USER1

Supplier Review Board – QA (SP_SCAR_QA)

SCAR_USER2

SCAR_USER3

Supplier Review Board – Operations (SP_SCAR_Operations)

SCAR_USER4

SCAR_USER5

Extension Request Approvers (SP_SCAR_ERApprovers)

SCAR_USER6

SCAR_USER7


SPSUBADMIN_User1

Supplier Management (SP_SCAR_Management )

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

386

Instruction Status







Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

387

Instruction Status







Complete

N/A

388

Instruction Status


Click the Build Data Structure icon next to the “SP_CFG_SCAR_Source” data structure and review the default options available for the Source drop-down field in the data structure.



Note: Make sure the “Other" option remains unchanged in the default options of the “SP_CFG_SCAR_Source” data structure during setup.



Complete

Default Custom

Analyzer Agent

NCMR

Audit

Audit Finding

Supplier Deviation

Supplier Scorecard

Other

List items:




Complete

389

Notes

390






Form InfoCard Types: SCAR

Form Numbering Series: SCAR Form (SCAR-xxxx)






Form Vaults: SCAR Draft

SCAR Release

SCAR Archive

Aborted Forms

Form Lifecycle: SCAR Forms

Roles

Roles: Supplier Management (SP_SCAR_Management )







Route: SCAR

391

Data Structures


SP_CFG_SCAR_Source

SP_TRANS_SCAR

Template Mappings

The following template mappings are created by the installer associated with the Supplier Corrective Action Solution Package. Refer to the Design Specification (SP-808) for the template mapping detail:

SCAR-ExtRequest

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Supplier Corrective Action Solution Package. Refer to the Design Specification (SP-808) for the EventCard mapping detail:

SCAR_Event

SCAR_Agent

Agent_SCAR

Reports


Report Names: Active SCARs

SCARs by Supplier

SCAR Responses Past Due

392

6. Open Items


393

Supplier Deviation

394

Supplier Deviation Installation and Configuration Checklist

1. Overview: Supplier Deviation

This document is intended to guide users through the process of installing and/or configuring the MasterControl Supplier Deviation Solution.

IMPORTANT:












395


Instruction Status




System Identified


Instruction Status




Supplier Deviation Complete

Already installed



Complete

Already installed




Complete

Already installed

Not Used

396

Instruction Status

This solution package has optional capabilities for form-to-form launching of other MasterControl solution packages.

If the MasterControl Supplier Corrective Action (SCAR) solution package is to be used, then select the following SP from the list:

SCAR

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Complete

397

Instruction Status

Menu(s) installed:


Install Test Users:



Go to Portal > User Management > Roles then click the edit icon next to each role and in edit security role window make sure that the test users have been associated with their appropriate roles as indicated below in the default column.



Enable the route:

Go to Process > Routes. In the Route Name column, locate Supplier Deviation.

In the Actions column of the Supplier Deviation row, click the Enable Route icon (green check mark) to enable the route.


Complete

398

Default Custom

Supplier Deviation Initiators (SP_SDEV_Initiators)

SDEV_User1

SDEV_User2

Supplier Deviation Development Representatives (SP_SDEV_DevReps)

SDEV_User3

SDEV_User4

Supplier Deviation Production Representatives (SP_SDEV_ProdReps)

SDEV_User5

SDEV_User6

Supplier Deviation Quality Assurance (SP_SDEV_QA)

SDEV_User7

SDEV_User8

Extension Request Approvers (SP_SDEV_ERApprovers)

SDEV_User9

SDEV_User10


SPSUBADMIN_User1

Supplier Deviation Initiators (SP_SDEV_Initiators)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________

399







Notes


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A

400

Instruction Status


If MasterControl Change Control is to be used (default): - Open the Supplier_Deviation.html file in any HTML editor, and

search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

- Save the file.

If no Change Control system will be used: - Open the Supplier_Deviation.html file in any HTML editor, and

search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

- Save the file.

If no Change Control system will be used, and the reference field is editable: - Open the Supplier_Deviation.html file in any HTML editor, and

search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

- Save the file.

Complete


If MasterControl Advanced Packet is to be used (default): - Open Supplier_Deviation.html file in any HTML editor and search the

section var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “MC” in the JS code.

- Save the file.

If no Advanced Packet will be used: - Open Supplier_Deviation.html file in any HTML editor and search the

section var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “None” in the JS code.

- Save the file.

Complete

If the SCAR form is to be launched from Supplier Deviation (default):

Supplier Corrective Action Type Selection (when SCARTYPE is set to ‘1’ - which represents SCAR form launch):

- Open the Supplier_Deviation.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

401

Instruction Status

If the SCAR form will *not* be launched from Supplier Deviation:

Supplier Corrective Action Type Selection (when SCARTYPE is set to ‘0’ - which represents no SCAR form launch, and the reference field is editable):

- Open the Supplier_Deviation.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

If MasterControl Supplier is to be used for the Supplier drop-down field, no further configuration is necessary. In order to use the Supplier Deviation form, Supplier InfoCards should be created in the system (MasterControl Supplier > Supplier InfoCard, Create InfoCards).

Complete

N/A







Complete

N/A

402

Instruction Status


Click the Build Data Structure icon next to the “SP_CFG_SDEV_Deviation_Category” data structure and review the default options available for the Deviation Category drop-down field in the data structure.





Complete

403

Default Custom

Change in Procedure

Change in Material

Change in Method

Nonconforming Material

Out of Tolerance

Cosmetic Defect

List items:

Click the Build Data Structure icon next to the “SP_CFG_SDEV_Development_Approval” data structure and review the default options available for the Development Approval drop-down field in the data structure.





Complete

Default Custom

Approve

Reject

List items:

Click the Build Data Structure icon next to the “SP_CFG_SDEV_Production_Approval” data structure and review the default options available for the Production Approval drop-down field in the data structure.





Complete

404

Default Custom

Approve

Reject

List items:

Click the Build Data Structure icon next to the “SP_CFG_SDEV_QA_Approval” data structure and review the default options available for the QA Approval drop-down field in the data structure.





Complete

Default Custom

Approve

Reject

List items:




Complete

405

Notes

406






Form InfoCard Types: Supplier Deviation

Form Numbering Series: Supplier Deviation Form (SDR-xxxx)






Form Vaults: Supplier Deviation Draft

Supplier Deviation Release

Supplier Deviation Archive

Aborted Forms

Form Lifecycle: Supplier Deviation Forms

Roles

Roles: Supplier Deviation Initiators (SP_SDEV_Initiators)








Route: Supplier Deviation

407

Data Structures


SP_CFG_SDEV_Deviation_Category

SP_CFG_SDEV_Development_Approval

SP_CFG_SDEV_Production_Approval

SP_CFG_SDEV_QA_Approval

SP_CFG_SDEV_Source

SP_TRANS_SDEV

Template Mappings

The following template mappings are created by the installer associated with the Supplier Deviation Solution Package. Refer to the Design Specification (SP-809) for the template mapping detail:

SupplierDev-SCAR

SupplierDev-ExtRequest

SupplierDev-ChangeControlAdv

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Supplier Deviation Solution Package. Refer to the Design Specification (SP-809) for the EventCard mapping detail:

SupplierDeviation_Event

SupplierDeviation_Agent

408

Reports


Report Names: Active Supplier Deviations

Supplier Deviations by Product

Supplier Deviations by Specification

Supplier Deviations by Category

Supplier Deviations by Disposition

409

6. Open Items


410

Supplier Scorecard

411

Supplier Scorecard Installation and Configuration Checklist

1. Overview: Supplier Scorecard

This document is intended to guide users through the process of installing and/or configuring the MasterControl Supplier Scorecard Solution.

IMPORTANT:




412










Instruction Status




System Identified


Instruction Status




Supplier Scorecard Complete

413

Instruction Status

Already installed



Complete

Already installed


If MasterControl Supplier Corrective Action (SCAR) solution package is to be used, then select the following SP from the list:

SCAR

Complete

Already installed

Not Used


Template Mappings

Complete


Data Structures

Complete

Already installed








IMPORTANT NOTE:

Complete

414

Instruction Status


Menu(s) installed:


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Supplier Scorecard.

In the Actions column of the Supplier Scorecard row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

415

Instruction Status

Supplier Management (SP_SSCARD_Management)

SSCARD_USER1

Supplier Review Board – QA (SP_SSCARD_QA)

SSCARD_USER2

SSCARD_USER3

Supplier Review Board – Operations (SP_SSCARD_Operations)

SSCARD_USER4

SSCARD_USER5

Extension Request Approvers

(SP_SSCARD_ERApprovers)

SSCARD_USER6

SSCARD_USER7


SPSUBADMIN_User1

Supplier Management (SP_SSCARD_Management)

______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________

Extension Request Approvers

(SP_SSCARD_ERApprovers)

______________________________

______________________________

______________________________


___________________________

___________________________

___________________________





416

Notes


Instruction Status



SP-FRM- Rev


Complete

N/A


Complete

N/A

If the SCAR form is to be launched from Supplier Scorecard (default):

Supplier Corrective Action Type Selection (when SCARTYPE is set to ‘1’ - which represents SCAR form launch):

- Open the Supplier_Scorecard.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 1 in the JS code.

- Save the file.

Complete

N/A

417

Instruction Status

If the SCAR form will *not* be launched from Supplier Scorecard:

Supplier Corrective Action Type Selection (when SCARTYPE is set to ‘0’ - which represents no SCAR form launch, and the reference field is editable):

- Open the Supplier_Scorecard.html file in any HTML editor, and search for var SCARTYPE. Make sure the SCARTYPE variable is set to 0 in the JS code.

- Save the file.

Complete

N/A

If MasterControl Supplier is to be used for the Supplier drop-down field, no further configuration is necessary. In order to use the Supplier Scorecard form, Supplier InfoCards should be created in the system (MasterControl Supplier > Supplier InfoCard, Create InfoCards).

Complete

N/A

Notes

418






Form InfoCard Types: Supplier Scorecard

Form Numbering Series: Supplier Scorecard Form (SCORE-xxxx)






Form Vaults: Supplier Scorecard Draft

Supplier Scorecard Release

Supplier Scorecard Archive

Aborted Forms

Form Lifecycle: Supplier Scorecard Forms

Roles

Roles: Supplier Management (SP_SSCARD_Management)



Extension Request Approvers (SP_SSCARD_ERApprovers)




Route: Supplier Scorecard

419

Data Structures

Data Structures: SP_CFG_SSCARD_Source

SP_TRANS_SSCARD

Template Mappings

The following template mappings are created by the installer associated with the Supplier Scorecard Solution Package. Refer to the Design Specification (SP-810) for the template mapping detail:

SupplierScorecard-ExtRequest

SupplierScorecard-SCAR

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Supplier Scorecard Solution Package. Refer to the Design Specification (SP-810) for the EventCard mapping detail:

SupplierScorecard_Agent

SupplierScorecard_Event

Reports


Report Names: Active Supplier Scorecards

Supplier Scorecards by Supplier

420

6. Open Items


421

Variance

422

Variance Installation and Configuration Checklist

1. Overview

This document is intended to guide users through the process of installing and/or configuring the MasterControl Variance Solution.

IMPORTANT:












423


Instruction Status




System Identified


Instruction Status




Variance Complete

Already installed



Complete

Already installed




Complete

Already installed

Not Used


Template Mappings

Complete

424

Instruction Status


Data Structures

Complete

Already installed








IMPORTANT NOTE:


Menu(s) installed:

Complete

425

Instruction Status


Install Test Users:






Enable the route:

Go to Process > Routes. In the Route Name column, locate Variance.

In the Actions column of the Variance row, click the Enable Route icon (green check mark) to enable the route.


Complete

Default Custom

Variance Initiators (SP_VAR_Initiators)

VAR_USER1

VAR_USER2

Variance Development Representatives

(SP_VAR_DevReps)

VAR_USER3

VAR_USER4

Variance Production Representatives (SP_VAR_ProdReps)

VAR_USER5

VAR_USER6

Variance Initiators (SP_VAR_Initiators)

______________________________

______________________________

______________________________

Variance Development Representatives

(SP_VAR_DevReps)

______________________________

______________________________

______________________________ Variance Production Representatives (SP_VAR_ProdReps)

______________________________

______________________________

______________________________

426

Instruction Status

Variance Quality Assurance (SP_VAR_QA)

VAR_USER7

VAR_USER8

Extension Request Approvers (SP_VAR_ERApprovers)

VAR_USER9

VAR_USER10


SPSUBADMIN_User1


______________________________

______________________________

______________________________


______________________________

______________________________

______________________________


___________________________

___________________________

___________________________





Notes

427


Instruction Status



SP-FRM- Rev

Complete

N/A


Complete

N/A


If MasterControl Change Control is to be used (default): - Open the Variance.html file in any HTML editor, and search for var

CHANGECONTROLMODE . Make sure the CHANGECONTROLMODE variable is set to “MC” in the JS code.

- Save the file.

If no Change Control system will be used: - Open the Variance.html file in any HTML editor, and search for var

CHANGECONTROLMODE . Make sure the CHANGECONTROLMODE variable is set to “None” in the JS code.

- Save the file.


- Open the Variance.html file in any HTML editor, and search for var CHANGECONTROLMODE. Make sure the CHANGECONTROLMODE variable is set to “Other” in the JS code.

- Save the file.

Complete

428

Instruction Status


If MasterControl Advanced Packet is to be used (default): - Open Variance.html file in any HTML editor and search the section

var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “MC” in the JS code.

- Save the file.

If no Advanced Packet will be used: - Open Variance.html file in any HTML editor and search the section

var CHANGECONTROLADVPACKET from code. And make sure the CHANGECONTROLADVPACKET variable is set to “None” in the JS code.

- Save the file.

Complete

429

Instruction Status







Complete

N/A


Click the Build Data Structure icon next to the “SP_CFG_Variance_Perspective” data structure and review the default options available for the Perspective drop-down field in the data structure.





Complete

430

Instruction Status

Default Custom

Prospective

Retrospective

List items:

Click the Build Data Structure icon next to the “SP_CFG_Variance_Vari_Category” data structure and review the default options available for the Variance Category drop-down field in the data structure.





Complete

Default Custom

Change in Procedure

Change in Material

Change in Method

Nonconforming Material

Out of Tolerance

Cosmetic Defect

List items:

Click the Build Data Structure icon next to the “SP_CFG_Variance_Dev_Apprvl” data structure and review the default options available for the Development Approval drop-down field in the data structure.





Complete

431

Default Custom

Approve

Reject

List items:

Click the Build Data Structure icon next to the “SP_CFG_Variance_Prod_Apprvl” data structure and review the default options available for the Production Approval drop-down field in the data structure.





Complete

Default Custom

Approve

Reject

List items:

Click the Build Data Structure icon next to the “SP_CFG_Variance_QA_Apprvl” data structure and review the default options available for the QA Approval drop-down field in the data structure.





Complete

432

Default Custom

Approve

Reject

List items:




Complete

Notes

433






Form InfoCard Types: Variance

Form Numbering Series: Variance Form (VAR-xxxx)






Form Vaults: Variance Draft

Variance Release

Variance Archive

Aborted Forms

Form Lifecycle: Variance Forms

Roles

Roles: Variance Initiators (SP_VAR_Initiators)

Variance Development Representatives (SP_VAR_DevReps)

Variance Production Representatives (SP_VAR_ProdReps)






Route: Variance

434

Data Structures


SP_CFG_Variance_Perspective

SP_CFG_Variance_Vari_Category

SP_CFG_Variance_Dev_Apprvl

SP_CFG_Variance_Prod_Apprvl

SP_CFG_Variance_QA_Apprvl

SP_TRANS_VAR

Template Mappings

The following template mapping is created by the installer associated with the Variance Solution Package. Refer to the Design Specification (SP-811) for the template mapping detail:

Variance-ExtRequest

Variance-ChangeControlAdv

EventCard Mappings


The following EventCard mapping is created by the installer associated with the Variance Solution Package. Refer to the Design Specification (SP-811) for the EventCard mapping detail:

Variance_Event

Reports


Report Names: Active Variances

Variances by Product

Variances by Specification

Variances by Category

Variances by Disposition

435

6. Open Items
