FDA Guidelines on Spreadsheet Validation
We monitor the latest FDA developments and FDA guidelines on spreadsheet validation
Here are published papers that explain the latest FDA guidelines on spreadsheet validation as well as industry wide views on Excel security. Certainly they are a useful starting point for undertstanding the scope of your project and introduce the best methodologies to use.
- 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
Upcoming conferences on spreadsheet validation
Nothing planned at present….
Recent conferences on spreadsheet validation
Discussion with the FDA on Spreadsheet Validation
In October 2004 we met with 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. As a result we were able to learn first hand about FDA requirements for spreadsheet validation. In addition we were able to advise the FDA on the validation issues facing the industry.
1. Firstly we discussed the Laboratory Information Bulletin. This outlines 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. We also 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. Again, this is an internal FDA procedure. You can download it here.
Within the documents spreadsheetvalidation.com is referenced and so is the DaCS software. We were very happy to have the final review of the second document prior to its release and of course we continue to monitor the FDA activities on spreadsheet validation.