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ABC System Integration ProgramSAP Interfaces

Business Process Requirements

THESE DOCUMENTS ARE THE PROPERTY OF ABC COMPANY CORPORATION AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN CONSENT OF ABC COMPANY CORPORATION.

ABC CompanySAP Interfaces Business Process Requirements

90518751 Rev/Ver AAPage 1 of 15

Table of Contents

1. Purpose..................................................................................................................................32. Scope.....................................................................................................................................33. Applicable Documents............................................................................................................34. Background............................................................................................................................35. Business Objectives...............................................................................................................36. Role Definitions......................................................................................................................47. Requirements Overview.........................................................................................................4

7.1. Regulatory.......................................................................................................................47.2. Overall Business Process Flow.......................................................................................57.3. General............................................................................................................................57.4. Critical Implementation Factors.......................................................................................5

8. Business Process Flows........................................................................................................68.1. Bionic Navigator (BN) 2.0 Interface.................................................................................68.2. Clientele Interface...........................................................................................................88.3. MediSoft Interface...........................................................................................................98.4. NetRegulus/NetRM Interface........................................................................................108.5. Sales Accelerator..........................................................................................................12

9. Security and User Administration Requirements..................................................................1410. Disaster Recovery and Backup Requirements.................................................................1411. Quality Records................................................................................................................1512. Approvals and Authorizations...........................................................................................1513. Electronic Records / Electronic Signatures Requirements...............................................15



1. PurposeThe purpose of this document is to specify the business process requirements which are driving the need of current ABC ancillary systems to interface and transfer data between those systems and Legacy ABC Company Corporation SAP systems. These interfaces do not currently exist in Legacy SAP. This initiative is part of the ABC System Integration Program (ABC Integration program)(NMSIP)

2. ScopeThe scope of this document is to integrate current DataFlo interfaces into Legacy SAP systems. Specifically, these are the interfaces covered:

Bionic Navigator 2.0

Clientele

MediSoft

NetRegulus/NetRM

Sales Accelerator

3. Applicable DocumentsDocument Name Document NumberNMSIP Program PlanGSM Business Process Requirements TemplateCorporate Policy on Electronic Records & SignaturesCorporate Policy on Quality System/Manufacturing Software and Computerized Systems

4. BackgroundRefer to NMSIP Program Plan.

5. Business ObjectivesThe business objectives are to mitigate ABC ’s business continuity risk with their current systems. The additional objectives are for ABC to leverage common Legacy platforms and implement IS capabilities for the ABC business, as well as to interface to Legacy SAP systems the current ancillary systems presently interfaced to the DataFlo system.

6. Role DefinitionsSince this document encompasses all interfaces to the SAP system that are required from a ABC perspective, there are various roles involved. See Table 1 below.



Table 1

Role Definition & ResponsibilitiesIS Business Process Team Drive efforts to identify business processes.

Lead business process documentation activities. Ensure SME consensus is reached on accuracy

and completeness of business process documentation.

Serve as primary owner of Functional BPR documents.

Software Quality Assurance Guide the team in developing the documentation required to meet the Corporate Policy on Quality System/Manufacturing Software and Computerized Systems. (90049863)

Act as independent reviewer for project documentation for Quality System

IS Validation Assist in the development of documentation Act as independent reviewer for project

documentation for Non-Quality System. Provide GSM and SCR Process direction Provide direction and guidance during all project

phases.Business Subject Matter Experts (SMEs)

Share knowledge of current business processes enabled by SAP.

Approve BPR when updates are required.

7. Requirements Overview

7.1. Regulatory

The regulatory requirements imposed upon the business processes contained in this document include HIPAA requirements concerning transmission and storage of Patient Health Information. Other regulatory requirements include those mentioned in Corporate Policy on Quality System/Manufacturing Software and Computerized Systems (PDM 90049863) and Corporate Policy on Electronic Records & Signatures (PDM 90049866). In turn, this assures compliance with applicable external regulations.

7.2. Overall Business Process FlowThe high level business process flow below represents the interdependencies between the various ancillary systems and their interfaces and the SAP R/3 system. These interfaces are new to the Legacy SAP system and connect to systems not currently used by Legacy These interfaces are either unidirectional or bi-directional.



Figure 1

7.3. General

Data transmission through the Clientele, MediSoft, and NetRegulus/NetRM interfaces are unidirectional while the data transmission through the BN2.0 and Sales Accelerator interfaces are bi-directional. The aforementioned interfaces will either transmit data once a day or throughout the day based on triggers which are specified in further detail in the Requirements Specification documents.

7.4. Critical Implementation Factors

The ancillary systems which will be connected to SAP through the interfaces specified in Figure 1 are critical to the business in the areas of Sales & Marketing, Insurance Reimbursement, Clinical, and Complaints. These systems are used for scheduling surgeries, managing inventory, tracking complaints, billing insurance, programming IPGs and tracking patient information.

8. Business Process Flows



8.1. Bionic Navigator (BN) 2.0 InterfaceBN2.0 is the latest version of the software, expected to be installed on the CP (Clinician’s Programmer) laptops in late 2009, which programs the IPG (Implantable Pulse Generator) devices. The Product Activation Portal is the website which orchestrates the CP activation and IPG firmware activation process. This interface is bi-directional, from and to SAP and the Product Activation Portal.

Data concerning the software installed on the CP devices and the firmware installed on the IPG devices will be stored in custom tables in SAP. This interface will be used to verify what software/firmware versions may be installed on a particular device and, once installed, the interface will be used to update the tables in SAP with the latest software/firmware installed on a particular device.

8.1.1. General Business Rules8.1.1.1. SAP shall have the ability to validate serial number, model number, and

software/firmware version and send authorization to Product Activation Portal.

8.1.1.2. SAP shall have the ability to translate the model number as reported in the field to the model number as stored in SAP.

8.1.1.3. SAP shall have the ability to generate an exception report listing installation authorizations given, but not confirmed.

8.1.1.4. SAP shall have the ability to generate a failure report listing all failed installations with failure code.

8.1.1.5. SAP shall have the ability to “clear” the exception condition (for installations not confirmed).

8.1.1.6. SAP shall have the ability to update the software/firmware version in device record(s) for traceability once the Product Activation Portal receives confirmation that an upgrade completed successfully.

8.1.1.7. SAP shall have the ability to store information pertaining to CP and IPG hardware including valid model numbers, firmware versions, and software versions.

8.1.1.8. SAP shall have the ability to maintain translation tables and valid models and versions tables using a user entry screen.

8.1.2. Inputs8.1.2.1. SAP shall have the ability to send approval or rejection of CP activation to

the Product Activation Portal.

8.1.2.2. SAP shall have the ability to send approval or rejection of IPG activation to the Product Activation Portal.

8.1.3. Activities8.1.3.1. BN2.0 interface shall have the ability to generate an error message if data

packages are not received/sent.



8.1.3.2. An error log shall be maintained to archive any error conditions that arise local to the SAP environment.

8.1.4. Outputs8.1.4.1. Product Activation Portal shall have the ability to send CP activation

request to SAP.

8.1.4.2. Product Activation Portal shall have the ability to send IPG firmware activation request to SAP.

8.1.4.3. Product Activation Portal shall have the ability to send CP key activation confirmation to SAP.

8.1.4.4. Product Activation Portal shall have the ability to send IPG key activation confirmation to SAP.

8.1.4.5. Product Activation Portal shall have the ability to send CP installation confirmation to SAP.

8.1.4.6. Product Activation Portal shall have the ability to send IPG firmware installation confirmation to SAP.

8.1.5. ParticipantsN/A

8.1.6. Entrance CriteriaMessage is triggered when activation is requested from the Product Activation Portal.

8.1.7. Exit CriteriaData is transmitted successfully between the Product Activation Portal and SAP.

8.1.8. Process Flow Chart(s)



8.2. Clientele InterfaceThe Clientele software manages the insurance authorization and billing for implantables and procedures. This interface is unidirectional from SAP to Clientele.

This interface is used to transfer new and updated master data from SAP to the Clientele program on a nightly basis. The purpose of this is to not duplicate effort and to ensure that SAP is the data source of record.

8.2.1. General Business Rules8.2.1.1. SAP shall have the ability to execute master data export once daily

Tuesday through Saturday between the hours of 2:00 am and 4:00 am PST.

8.2.2. Inputs8.2.2.1. SAP shall have the ability to send Surgical Center master data (Hospitals,

Surgical Centers, etc.) to Clientele.

8.2.2.2. SAP shall have the ability to send Surgical Center Role data to Clientele.

8.2.2.3. SAP shall have the ability to send Medical Professional master data to Clientele.

8.2.2.4. SAP shall have the ability to send Medical Professional Role data to Clientele.

8.2.2.5. SAP shall have the ability to send Patient master data to Clientele.

8.2.2.6. SAP shall have the ability to send Patient Role data to Clientele.

8.2.3. ActivitiesN/A

8.2.4. OutputsN/A




8.2.6. Entrance CriteriaMessages are triggered when new Patient, Medical Professional, and/or hospitals/surgical center data is entered into Legacy SAP or when Patient, Medical Professional, and/or hospital/surgical center data is updated in Legacy SAP.

8.2.7. Exit CriteriaData successfully transmitted from Legacy SAP to Clientele.


8.3. MediSoft InterfaceThe MediSoft software generates the insurance claim forms for all patient externals (e.g., remote controls, chargers, adhesive pads). This interface is unidirectional from Legacy SAP to MediSoft.This interface is used to transfer new and updated master data from SAP to the MediSoft program on a weekly basis. The purpose of this is to not duplicate effort and to ensure that SAP is the data source of record.

8.3.1. General Business Rules8.3.1.1. A user shall have the ability to execute the importer when no users are

logged into the Medisoft system.

8.3.1.2. Data exports shall be available at a frequency of once per week.

8.3.2. Inputs8.3.2.1. ImportMax shall have the ability to receive Patient demographic data from

SAP on a weekly basis.

8.3.3. ActivitiesN/A

8.3.4. OutputsN/A




8.3.6. Entrance CriteriaMessages are triggered when new Patient demographic data is entered into Legacy SAP or when Patient demographic data is updated in Legacy SAP.

8.3.7. Exit CriteriaData transmitted successfully from Legacy SAP to MediSoft.


8.4. NetRegulusInterfaceThe NetRegulus software is used for the storage and reporting of non-conformances and complaints. This interface is unidirectional from SAP to NetRegulus.This interface is used to transfer new and updated master data from SAP to the NetRegulus program on a nightly basis. The purpose of this is to not duplicate effort and to ensure that SAP is the data source of record.

8.4.1. General Business Rules8.4.1.1. SAP shall have the ability to export new and updated information on

facilities, medical professionals, patients, RMAs and product registrations

8.4.2. Inputs8.4.2.1. SAP shall have the ability to export new and updated surgical center

information to NetRegulus nightly.

8.4.2.2. SAP shall have the ability to export new and updated surgical center division information to NetRegulus nightly.

8.4.2.3. SAP shall have the ability to export new and updated medical professional information to NetRegulus nightly.

8.4.2.4. SAP shall have the ability to export new and updated medical professional centers information to NetRegulus nightly.

8.4.2.5. SAP shall have the ability to export new and updated medical professional division information to NetRegulus nightly.

8.4.2.6. SAP shall have the ability to export new and updated patient information to NetRegulus nightly.



8.4.2.7. SAP shall have the ability to export new and updated patient division information to NetRegulus nightly.

8.4.2.8. SAP shall have the ability to export new and updated RMA information to NetRegulus nightly.

8.4.2.9. SAP shall have the ability to export new and updated RMA Status information to NetRegulus nightly.

8.4.2.10. SAP shall have the ability to export new and updated RMA Notes information to NetRegulus nightly.

8.4.2.11. SAP shall have the ability to export new and updated RMA Print information to NetRegulus nightly.

8.4.2.12. SAP shall have the ability to export new and updated product registration information to NetRegulus nightly.

8.4.2.13. SAP shall have the ability to export new and updated observations to NetRegulus nightly

8.4.2.14. SAP shall have the ability to export new and updated issues to NetRegulus nightly.

8.4.3. Activities8.4.3.1. NetRegulus admin group shall be notified via email of any failed import

attempts.

8.4.4. OutputsN/A


8.4.6. Entrance CriteriaMessages are triggered by updated Facilities (Center), Medical Professional, Patient, Product Issue and/or Product Registration information in Legacy SAP.

8.4.7. Exit CriteriaData is transmitted successfully between NetRegulus and Legacy SAP.




8.5. Sales AcceleratorSales Accelerator consists of the handheld devices and a website hosted by the vendor. The handheld device is In Scope for this project. This interface is bi-directional.

This interface is used to transfer new and updated master data from SAP to the Sales Accelerator program through out the day, based on various triggers. The purpose of this is to not duplicate effort and to ensure that SAP is the data source of record.

8.5.1. General Business Rules8.5.1.1. Ability to enable Sales Reps in the field to access patient, surgeon,

account, surgery, pricing, inventory, and stop ship information.

8.5.1.2. Ability to enable Sales Reps to send sales order, inventory transfer, purchase order number, and patient information to SAP.

8.5.1.3. Sales Accelerator shall have the ability to scan products using HIBC, HIBC barcodes with formatting errors, and unencoded barcodes.

8.5.1.4. Sales reps must be able to export a procedure and have accurate account specific pricing when submitting the order.

8.5.1.5. Sales rep must be able to select a shipment number from a list of shipments sent to them when performing a DC Shipment Incoming Transfer.

8.5.1.6. Sales Accelerator user shall have the ability to export a procedure that includes explants and be able to select from a list of explants.

8.5.1.7. Sales Accelerator user shall have the ability to export a procedure that includes implantables, field externals, and used and consumed.

8.5.1.8. The GHX interface should have the ability to export orders with and without authorization.

8.5.2. Inputs8.5.2.1. The GHX interface shall have the ability to import ship-to hospital data.

8.5.2.2. The GHX interface shall have the ability to import user/sales rep data.

8.5.2.3. SAP shall designate non-sales rep users in the user/sales rep data import file.



8.5.2.4. The sales rep import file shall include all rep partnering locations (e.g., CI, FE).

8.5.2.5. The sales rep import file shall include an optional sales rep/user email address field.

8.5.2.6. The GHX interface shall have the ability to import contacts/surgeon data.

8.5.2.7. Product file must be filtered to only include active products.

8.5.2.8. The GHX interface shall have the ability to import inventory data.

8.5.2.9. The GHX interface shall have the ability to import pricing data.

8.5.2.10. The GHX interface shall have the ability to import shipment data.

8.5.2.11. The GHX interface shall have the ability to import surgery/implant tracking data.

8.5.2.12. The GHX interface shall have the ability to import patient data.

8.5.2.13. The GHX interface shall have the ability to import blacklist/stop ship data.

8.5.2.14. The GHX interface shall have the ability to import customer account data.

8.5.2.15. The GHX interface shall have the ability to import contact data.

8.5.2.16. The GHX interface shall have the ability to import contact center data.

8.5.3. Activities8.5.3.1. Audits shall be based off a nightly “snapshot” of the inventory (external

inventory reconciliation).

8.5.4. Outputs8.5.4.1. The GHX interface shall have the ability to export patient data that needs

to be processed.

8.5.4.2. The GHX interface shall have the ability to export inventory transfer data that needs to be processed.

8.5.4.3. The GHX interface shall have the ability to export complete orders (with PO number filled in) or incomplete orders (with no PO number filled in).

8.5.4.4. The GHX interface shall have the ability to export sales order data from the client application.

8.5.4.5. The GHX interface shall have the ability to export patient data.

8.5.4.6. The GHX interface shall have the ability to export inventory transfer data .

8.5.4.7. The GHX interface shall have the ability to export inventory transfer data from the client application based on an SA user submitting a transfer.

8.5.4.8. The GHX interface shall have the ability to export P.O. data.



8.5.4.9. The GHX interface shall have the ability to export P.O. data from the client application based on an SA user submitting a sales order.

8.5.4.10. The GHX interface shall have the ability to export procedures from the client application based on an SA user creating a procedure.


8.5.6. Entrance CriteriaVarious actions will trigger data transactions between Legacy SAP and Sales Accelerator. These will be delineated in the Requirements Specification document.

8.5.7. Exit CriteriaData was transmitted successfully between Legacy SAP and Sales Accelerator.


9. Security and User Administration RequirementsThe processes described in this document are automated interfaces and only require security which is necessary to meet regulatory requirements related to ERES and HIPAA.

10. Disaster Recovery and Backup RequirementsThe disaster recovery and backup requirements of SAP are the same for all business functions, and thus are defined in the Master SAP BPR, not in this document.



11. Quality RecordsThe NetRegulus/NetRM Interface will receive Quality Records from SAP in the form of RMA and Complaint records.

12. Approvals and AuthorizationsThis document describes interfaces associated with transmitting data to and from SAP and as such does not deal with any documents that require approvals or authorizations.

13. Electronic Records / Electronic Signatures RequirementsThe interfaces specified in this document transmit Electronic Records and therefore are subject to all rules and regulations specified in Corporate Policy on Electronic Records & Signatures (PDM 90049866).

