Spreadsheet Validation Documentation
World Leaders in Validation Methodology. Learn how to do Spreadsheet Validation.
Why risk a resource intensive project to teams with little or no spreadsheet validation experience?
Instead CSV Compliance can provide you with detailed user requirement specifications and comprehensive qualification protocols. Together they provide a methodology that brings your validation up to scratch.
Below you’ll find a series of published papers which explain our spreasheet validation methodology. They are a useful starting point for undertstanding the scope of your project and as well as how we can bring our compliance expertise to help you.
- Download an overview of how we perform Excel Spreadsheet Validation
- Download a description on how to develop Spreadsheet Specifications
- Download a description on how we undertake Spreadsheet Testing
Back in October 2004 we had a meeting Dennis Cantellops, QA Manager for the US FDA San Juan District in Puerto Rico. Dennis is widely recognised as the FDA’s foremost expert on spreadsheet use and spreadsheet validation. The aim was to learn from the FDA their requirements for spreadsheet validation and to advise the FDA on the spreadsheet validation issues facing the industry.
1. Firstly, we discussed the Laboratory Information Bulletin of what the FDA expect to see when you validate a multi user spreadsheet (i.e. a spreadsheet that is used multiple times, or by multiple users, such as a spreadsheet template). It is an internal FDA procedure. You can download it here.
2. Secondly, we discussed the Laboratory Information Bulletin of what the FDA expect to see when you use a single user spreadsheet. This method of spreadsheet use is not however very common in regulated industries. The document is an internal FDA procedure. You can download it here.
Within the documents spreadsheetvalidation.com is referenced and so is the DaCS software. As a result CSV Compliance are delighted to have the final review of the second document prior to its release and we continue to monitor the FDA activities on spreadsheet validation.