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FDA News on Spreadsheet Validation

New Developments

Upcoming conferences on spreadsheet validation.

Tues 18th July 2017. FDANews Spreadsheet Validation 2017.

 

Introducing the new DaCS Audit Trail Review Feature

Meet recent FDA and MHRA guidance on undertaking routine audit trail reviews and maintain the reviews with your electronic records. See how DaCS can help filter out, present and maintain audit trail and audit trail review activities.

Existing Documents and Previous Discussion

The FDA Laboratory Information Bulletins are available for download from the links on the right of this page.

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.

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.

Testimonial

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"spreadsheet applications should be protected with the safeguards identified in 21 CFR Part 11........The security, audit trails and true electronic signatures can be implemented by software and services such as what is available from the company Wimmer Systems" (now Finsbury Solutions and CSV Compliance)

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FDA Multi-user Laboratory Information Bulletin.

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" another approach to use the single-user workbook file is to add extra security, such as audit trails, and true electronic signatures which can be implemented by software and services such as that available from the company Wimmer Systems" (now Finsbury Solutions and CSV Compliance)

" the Spreadsheet Specification and Reporting Tool, can be used to audit the single-user workbook file templates during the testing and verification stages "

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FDA Single-user Laboratory Information Bulletin.

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