Authors
David Harrison & David A. Howard
Abstract
GxP critical spreadsheets need to undergo specification to ensure that the user's needs and the spreadsheet's functionality is clearly defined and documented.
This paper describes a pragmatic approach to the specification of Excel spreadsheets using a single generic document. The approach described is easily transferred to other simple systems such as databases and standalone instrumentation.
This continues the series of short articles describing a generic process for validating Excel Spreadsheets. A previous article gave an overview to the process, whilst a subsequent topic will cover the testing and qualification.
Sample
Outline of the spreadsheet specification document:
- Section 1 – Introduction.
- Section 2 – System overview.
- Section 3 - User requirements.
- Section 4 – Functional specification.
- Section 5 – Glossary.
- Section 6 – References.
- Appendix A – User requirements table details.
- Appendix B – Functional specification and worksheet contents.
- Appendix C – Workbook display & printouts.
- Appendix D – Macros included in workbook.
- Appendix E – Training records.
- Appendix F – Risk assessment.
Publication
2007, Pharma IT Journal, Volume 1, Number 3, July, pages 29-35
Full article
A pragmatic approach to the specification of Excel spreadsheets - Part 2
Also see
A pragmatic approach to the validation of Excel spreadsheets - Part 1
A pragmatic approach to the testing of Excel spreadsheets - Part 3
