giqar - marzo 20051 vesms validated electronic spreadsheets management system marino gobetti...

GIQAR - Marzo 2005 1

VESMSValidated

Electronic

Spreadsheets

Management

System

Marino GobettiInformation Communication Technology QANerviano Medical Sciences


Business needs

Validated Excel Spreadsheets• Pfizer audit observation • Many FDA 483s on the subject

Spreadsheets 21 CFR Part 11 compliant• Security & Data protection• Audit trail• E-Signature


Options

• From Vendors– DaCS (Data Compliance System)– NuGenesis ® SDMS– Scientific Software ® RSME

• In-house development– First experience of development of a GXP

computer system in Nerviano


Pros and Cons

In-house Vendor

Cost Low High

Implementation time

Long Short

Customization Easy Costly

Flexibility High Limited

Validation

Development

Compliance

Spreadsheets

Compliance

Spreadsheets

Integration with current systems

Yes No


Goals

Excel Spreadsheets Validation

Integration of Excel Spreadsheets within IDARS System


Excel Spreadsheets

Excel Spreadsheets (Not validated)

• Enforce procedural controls• Limiting functionality (menu/button/shortcut key)• Macros to enforce controls• Event handlers (open, close, print, save, etc.)

• Password protection• VBA macros, Charts, Cells, Objects

• No audit trail

• No Excel file creation


IDARS

IDARS system (Validated archive system)

• IDARS permissions and roles

• Read-only files

• E-sig on PDF files

• Version-based audit trail


Flow Diagram

e-rec + e-sig

Development

Excel Spreadsheet

*.pdf file*.xls file(master copy)

*.pdf file + e-sig

IDARS

*.xls filemaster copy

Data entry

*.pdf file

e-sig


Validation Strategy

Compliance Functionality

Spreadsheet Functionality

Incr

easi

ng C

ost

Full Validation Compartmentalized Validation

Standardizing the compliance functionality allows you to validate that part once only. It does not need to be repeated for each spreadsheet. You just need to do a minimal amount of compliance testing to demonstrate the individual spreadsheet works in that environment. With a large number of spreadsheets, the savings can be substantial.

One Spreadsheet

Compartmentalized Validation


Validation

VESMS went through a full Computer Validation cycle satisfying all the 12 elements of the QA Standard 0036

Project analysis

Spreadsheet designSpreadsheet development

System test

Project plan

Validation plan

System design

System development

Maintenance

Implementation

Spreadsheet test


VESMS Features

VESMS is a modular system made of a common basis and separate Excel applications for each type of calculation

VESMS relies on the IDARS system for a secure and validated data archival

Users work on validated unchangeable Excel templates; generate, store, and sign only PDF files


VESMS Benefits

• Validated macros and formulas• Standardized calculation and reporting• Comprehensive and consistent output• No need to double-check calculations• e-Rec / e-Sig compliant with 21 CFR Part 11• Effective and efficient archiving system• Easy retrieval of previous results• Easy sharing of results• No qualification needed for client PCs• A step towards paperless workflow• Minor validation effort for new spreadsheets


Timelines & Resources

• Start date 19 May 2004

• Implementation date 16 November 2004

• External costs (dev. and val.) = 0.00 €

• No additional maintenance cost for the future

• 20 Acrobat licenses: 5700 €(licences also available for other applications)


Conclusions

All Departments, in any Business Unit, that need to use Excel spreadsheets to perform repeated calculations in a validated environment can develop specific spreadsheets to be included in VESMS system.

The data are e-Records with e-Signature compliant with FDA 21 CFR Part 11 and can be used for any internal and external regulated activity.


Consultancy

VESMS Team is available for consultancy

.......on demandVESMSTeam

giqar - marzo 20051 vesms validated electronic spreadsheets management system marino gobetti...

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