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

1 2

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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