Authors
David A. Howard & David Harrison
Abstract
Many GxP critical spreadsheets need to undergo validation to ensure that the data they generate is accurate and secure.
This paper describes a pragmatic approach to the validation of Excel spreadsheets using the principals of GAMP 4.
The validation lifecycle requirements are met using a generic documentation set which allows spreadsheet validation and implementation with two documented deliverables. Compliance with the user's applicable regulations is achievable using this flexible and cost effective process.
This is the first of a series of short articles describing a generic process, as developed by ABB Engineering Services, for validating Excel Spreadsheets; future articles in this series will include the following topics:
- A pragmatic approach to the development and specification of Excel spreadsheets.
- A pragmatic approach to the testing of Excel spreadsheets.
Sample
An example spreadsheet validation process is depicted in this figure.
The approach provides a pragmatic solution to a common compliance concern, reducing risk with a cost effective and repeatable process.
The approach can be adapted to any sized inventory of spreadsheets and remains flexible enough to fit into individual company's computer systems validation policies.
Publication
2007, Pharma IT Journal, Volume 1, Number 2, April, pages 30-35
Full article
A pragmatic approach to the validation of Excel spreadsheets - Part 1
Also see
A pragmatic approach to the specification of Excel spreadsheets - Part 2
A pragmatic approach to the testing of Excel spreadsheets - Part 3
