abb excel solution overview
TRANSCRIPT
ABB Process
Solutions
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Excel Spreadsheet Validation
& Wimmer DaCS™
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Do any of these apply to you?
Do you see a long list of spreadsheets that need remediation against Validation Requirements or 21 CFR Part 11?
Have you read the latest guidelines on Risk based Remediation and 21 CFR Part 11 and need to discuss how best to implement spreadsheets?
Are you feeling concerned that spreadsheets are impacting compliance and a potential source of adverse observations?
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Very Serious
Minor Concern
What are the Problems with Excel Spreadsheets?
Lack of ValidationSecurity
TraceabilityNumber in use
Awkward
Logistical Nightmare
Incr
easi
ng
Co
st
Possible Shutdown
Probable 483
Possible 483
Incr
easi
ng
Ris
k
Prolonged Audit
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Example : Specific Client Problems Found Risk Likelihood Low Medium High High Medium
Risk Impact
Low
Probability of Detection Low Medium High
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Risk Classification
3
SecurityAnyone can access the spreadsheet Saved Records (Spreadsheet) can be overwritten
TraceabilityChanges to validated formulas can occur undetectedRetrospective changes to saved data can occur undetected
Validation ConcernsHow can you validate a system with these inherent concerns?Each spreadsheet is custom (GAMP Cat 5)
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Specific areas
QCFinal Product Assays In-process AssaysRaw Material Assays
ClinicalClinical Study Conclusions Clinical Study ReportsResearch Data
ProductionBatch Release Calibration trackingCalculation of yields
QASOP Tracking Training Record TrackingTrend Monitoring
Risk Likelihood Low Medium High High Medium
Risk Impact
Low
Probability of Detection Low Medium High
1 2
Risk Classification
3
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What Would ABB Do?
Nothing ! Review potential options
Review solutions
Develop own VB
The ABB Excel Validation Solution
GAMP 5
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BenefitsFamiliar Standard Product
Avoids customisation Compliant Use
Avoid 483’s Minimise validationInexpensive option
Fully managed service
DriversMCA and FDA cGMPs
New Risk based approachThe need for CSV in pharms
21 CFR Part 11Avoidance of customisation
Most companies have and use Excel extensively
The ABB Proposed Solution
Easy to Validate (or justification for not validating)
Useable in a regulated environment
Part 11 compliance with E-Sigs
Excel spreadsheets that are:
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The Full ABB Solution
You give us your current spreadsheets
Spec Ver1.0
We give you fully validated spreadsheets and validated
environment
IQ/OQ Ver1.0
Controlled and Validated Environment
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The Full Part 11 Compliant Solution
1. Excel “add-on” with full audit trail and logical security
2. Viable & working solution
3. Cost effective to implement new and existing spreadsheets
4. Integration & embedding with other applications that use spreadsheets
5. Best known solution (and NOT GAMP 5)
Wimmer Systems. DaCS (Data Compliance System)
(www.wimmersystems.com)
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Excel Spreadsheet Validation
using DaCS™
Demonstration
(Data Compliance System)
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The ABB Spreadsheet Validation Process
Install and Configure DaCS
Software
Produce Spreadsheet Qualification
ProtocolProduce
Spreadsheet Specification
Spreadsheet SOP
Spreadsheet Reformatting
Execute Spreadsheet Qualification Protocol
DaCS Specifications
Execute DaCS IQ Protocol DaCS User
Manuals
DaCS Controlled
Environment
Configure Windows Environment
Execute DaCS OQ Protocol
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