Excel Spreadsheet ABB Life Sciences ValidationExcel+Solution+Overview.pdfExcel spreadsheets that can...
Transcript of Excel Spreadsheet ABB Life Sciences ValidationExcel+Solution+Overview.pdfExcel spreadsheets that can...
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Excel SpreadsheetValidation& Wimmer DaCS™
ABB Life SciencesTel +44 (0)1642 [email protected]
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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
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Environ
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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