Garrett O. Mullen - Waters Corporation · The electronic alternative to the paper lab notebook ©2012 Waters Corporation 11 ... Audit Trail ©2012 Waters ... advantages ©2012 Waters

©2012 Waters Corporation 1

Garrett O. Mullen


NuGenesis 8 Featuring Lab Execution Technologies



Capture

Catalog

Data Reuse

E-Records Lifecycle Management


NuGenesis SDMS 8

Captures and catalogs all data types - files & documents

Easy search, retrieval and re-purposing

Web browser based

Compliant ready

Data Retention Policy Aware

R&D, QA, Business

The CorporateKnowledge Center


The Power of Integrating SDMS into Your Overall Business Process

Data Consumers

Data SourcesLab Instrumentation Office

Applications

Waters NuGenesis SDMS

View

Extract

LIMSVisualizationand Analytics

SoftwareData

WarehousesDiscovery

and ClinicalDatabases



One ELN

Free Flow - Unstructured

Process Driven - Structured


ELN 8

User Configured for any laboratory typeGeneral purpose digital annotation toolConsolidated Documentation/ annotationInventory Management– Reagents/Instruments

Sample TrackingReporting– Scientific– Business– Legal / Patent (IP)

Traceability to source dataCompliant ready

The electronic alternative to the paper lab notebook


ELN Document Editor


Embed Applications

Integrate software via COM technology


Integrate Templates

Save time with pre-formatted entriesEasy to fill out with less errors and higher content quality, e.g. use Microsoft Word forms to create interactive templates

Generate entire document templates

Use existing software templates, e.g. Excel worksheets

Modify and administrate templates within the ELN



Instrument Inventory

Consumables Inventory

Fit-For-Use Checks


Inventories



Empower & MassLynx

Any Scientific Software

Simple Devices

Business Systems


SDMS Project Browser


Direct Access to Empower


Simple Devices -Balance Interface

<CR> 9.876 uni

Stock No. 123456

Compound Source Exp Desired (mg) Actual (mg)

a: Diphenhydramine VMR 22-Nov-07 40 23.13

b: Pseudoepherine HCL Bayer 11-Jan-08 600 6.72

c: Dextromethorphan HBr BASF 10-Feb-08 200 24.16

Table Continued. Batch No.

a: Diphenhydramine DIP-003

b: Pseudoepherine HCL PSD-02

c: Dextromethorphan HBr Dextromethorphan Hbr39398.8115751157

Compound Source Exp Desired (mL) Actual (mL)H2O-01 Waters 10-Feb-08 50 49.98

Acceptable ( Conc (mg/mL) Total (mg)Std. A N 0.05 54.01

Balance ID No. Cal/Qual DateSrN-11679-B4 4-Nov-07

Step 2: Add 50 mL of purified WaterDextromethorphan HBr

34 Maple Street, Milford MA 01757Phone: 1-800-252-4752 Fax: 1-508-482-2004

Stock Preparation

Confidential.

Step 1: Weigh the following into a clean dry 100 mL class "A" volumetric flask.

Step 3: Add purified Water to volumetric flask bringing solvent level to 100 mL.

Note: Swirl (sonicate if necessary) to dissolve completely.

Standard Details:

Balance Details:

<CR> 9.876 unit mg 09/08/2008 wli4345a tare y<CR><LF>9.876 mg

9.876

9.876 9.876 mg



Electronic LabExecution Methods

Predefined

Automation

Proper Sequence


Combine Procedure and Data Entry Using Electronic Forms

Procedure

Data Entry

Stock No. 123456

Compound Source Exp Desired (mg) Actual (mg)

a: Diphenhydramine VMR 22-Nov-07 40 23.13

b: Pseudoepherine HCL Bayer 11-Jan-08 600 6.72

c: Dextromethorphan HBr BASF 10-Feb-08 200 24.16

Table Continued. Batch No.

a: Diphenhydramine DIP-003

b: Pseudoepherine HCL PSD-02

c: Dextromethorphan HBr Dextromethorphan Hbr39398.8115751157

Compound Source Exp Desired (mL) Actual (mL)H2O-01 Waters 10-Feb-08 50 49.98

Acceptable ( Conc (mg/mL) Total (mg)Std. A N 0.05 54.01

Balance ID No. Cal/Qual DateSrN-11679-B4 4-Nov-07

Step 2: Add 50 mL of purified WaterDextromethorphan HBr

34 Maple Street, Milford MA 01757Phone: 1-800-252-4752 Fax: 1-508-482-2004

Stock Preparation

Confidential.

Step 1: Weigh the following into a clean dry 100 mL class "A" volumetric flask.

Step 3: Add purified Water to volumetric flask bringing solvent level to 100 mL.

Note: Swirl (sonicate if necessary) to dissolve completely.

Standard Details:

Balance Details:


Invoke SOP from External System


Restricted Access to Forms


Electronic Signatures & Workflow



Manage & TrackSample Test Request

Ensure ProductsMeet Specifications


NuGenesis 8Streamline Documentation Workflows


Sample Tracking


Reporting



Compliance Ready

Electronic Records

Electronic Signature

Data & Result Traceability


Audit Trail


Report Final Results

Create paper-equivalent printouts

Customize layouts

Facilitate hand-written signatures on printed reports


IP Protection and Security

In order to be a true replacement for paper notebooks electronic versions need– a sustainable reviewing and witnessing process

– high level of transparency for all entries made in the notebook

– solid content protection and anti-fraud provisions

The overall concept must give higher security than the paper process in addition to productivity gains and corporate advantages


Making the Transition

Make all disparate data work togetherSolve data variabilityReduce high administrative costs and non-value added tasksShare and collaborate across the enterpriseComply with 21 CFR 11 and IP needs

Waters Laboratory Informatics…makes it happen!!!


Enterprise Solutions - Service Offerings

Planning & Consulting

Project Management

Implementation Support

Integration Services

Validation

Training

Maintenance & Support


Documents

Garrett O. Mullen - Waters Corporation · The electronic alternative to the paper lab notebook ©2012 Waters Corporation 11 ... Audit Trail ©2012 Waters ... advantages ©2012 Waters