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Excel SpreadsheetValidation& Wimmer DaCS™

ABB Life SciencesTel +44 (0)1642 372372wimmer.system@gb.abb.com

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Some of ABB’s Pharmaceuticals customers

Customers and AlliancesAbbot, Aventis, Bayer, Bristol-MyersSquibb, Eli Lilly, Fresenius,GlaxoSmithKline, Hoechst MarionRoussel, Knoll, Merck, Novartis,NovoNordisk, Pharmacia, RhonePoulenc, Roche, Pfizer, Schering,AstraZeneca

ABB is a partner with:Validations experience and knowledgeof regulatory requirements

Enterprise-wide integration and batchprocess automation experience

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The Product

Excel spreadsheets that can be used in a regulatedenvironment

Validated (or justification for not validating)

If required Part 11 compliance

If required Electronic Signatures

Are you using Excel for•Analytical Assays? Document Tracking?•Training Records? GxP critical activities?

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The Full Solution

You give us yourcurrent spreadsheets

Spec Ver1.0

We give you fully validatedspreadsheets and validated

environment

IQ/OQ Ver1.0

Controlled andValidated

Environment

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Click Here for theABB/WimmerSystems Excel

Process

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The Full Part 11 Compliant Solution

Excel with full audit trail and logical security

Only viable solution at present (and the best known)

Wimmer Systems.

DaCS (Data Compliance System)

(www.wimmersystems.com)

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Wimmer DaCS™ - Main Components

User AccountDatabase

dacsuser.mdb

MicrosoftExcel

Excel.exe

DaCS.xlsInterface

WorkbookOffice Librarymso9.olb

wsdacs.exeActiveX EXE

Excel Libraryexcel9.dll

DaCS-FormatExcel Workbook

*.xlsRegular Excel

Workbook

*.xls

WindowsLibraries

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DaCS in OperationOpened from an “Interface Workbook”

Login

DaCS Now Loaded and Running..

User Name Display

DaCS Menu

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Demo Account Management

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Demo Spreadsheet

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Demo Spreadsheet

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Audit Trail

Value changed from 0.58to 0.64

Entry box for‘Reason’

(configurableoption)

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Audit Trail

Value changed shown inaudit trail

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Can your current validation verify:•An independent audit trail?•Log-on security for the applicationand spreadsheets?•That your data is secure and thatsaved data can not be modified?

Avoid the ADDITIONAL EXPENSE of customised alternatives to Excelsuch as Databases and LIMS.

DON’T RISK COMPLIANCE with “standard” Excel & XLA templates.

Continue to use the flexibility, familiarity and interconnectivity of Excel.

Wimmer DaCS™ - Excel Solution

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The ABB Validation Process

Procedural Controls

Spreadsheet Qualification

Reverse Engineer Spreadsheet Specifications

Spreadsheet Conversion

Training

DaCS Specification, Installation & Qualification

Technical Support

Technology Development

EndUser

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The ABB Validation Process - the spreadsheet

Ver1.0 Ver1.1

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The ABB Validation Process - the specifications

ABB Spreadsheet specification• Spreadsheet Specification (Custom)

Wimmer DaCS specification• Functional Specification (Generic)

FDS Ver1.0

FDS Ver1.1

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The ABB Validation Process - the environment

Firewall

Secure

Protec

ted

Environ

ment

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The ABB Validation Process - the qualification

ABB Spreadsheet specification• Spreadsheet Qualification (Custom)

Wimmer DaCS qualification•Functional Testing (Generic)

•Installation Qualification•Operational Qualification

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The ABB Validation Process - the procedures

ABB Spreadsheet procedures• Spreadsheet Maintenance

•Spreadsheet Operation

Wimmer DaCS Manuals•System Administrator Manual

•User Manual

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The ABB Validation Process - the support

Technical SupportLocal Support

Global SupportConsultancy

Resources