Previous Discussion

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 goals of the meeting were to learn from the FDA their requirements for spreadsheet validation and to advise the FDA on the spreadsheet validation issues facing the industry as seen by ABB.

1. 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. 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. We were very happy to have the final review of the second document prior to its release and we continue to monitor the FDA activities on spreadsheet validation.

New Developments

At present there are no new FDA announcements on spreadsheet validation. To see whats happening in the industry please look at our case studies and press releases.