Q: You’ve told us previously that FDA requires spreadsheet validation — at least for ones that handle regulated data. Can you be more specific about how I validate a spreadsheet? And what kind of objective evidence do I need to support spreadsheet validation?
A: Spreadsheet validation depends on your intended use of the spreadsheet. Remember, you’re not validating Excel or whatever off-the-shelf spreadsheet program you use — you’re validating the specific spreadsheet you create. Start your development by documenting your requirements. Be sure to include requirements for the security of the record (both logical and physical) and make sure you’ll be aware of any loss or corruption of the data or record (what FDA calls an audit trail).
FDA’s ORA Laboratory Manual has a section on validating spreadsheets for laboratory use: Volume III – 4.5 Development and Validation of Spreadsheets for Calculation of Data. I would use this reference to determine how much you need to do.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]Objective evidence is not and never has been the words, “pass/fail”, “yes/no”, “as expected”, or “true/false”.[/pullquote]
Addressing your second question, objective evidence is data that can be reproduced by a second individual if he/she performs the same set of instructions in the same manner. Objective evidence is not and never has been the words, “pass/fail”, “yes/no”, “as expected”, or “true/false”. Those words are conclusions and do not meet FDA’s expectations for objective evidence.
Objective evidence demonstrates proper performance and functionality. It can include printouts, screen shots, videos running in the background, key captures, or written descriptions of what occurred or what was observed by the tester. It’s important you have sufficient objective evidence proving the spreadsheet or database does what you intend it to do — and that it performs exactly as you need and expect it to.
Answered by Denise Dion, EduQuest Vice President of Regulatory and Quality Services, and co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class. Denise was an expert investigator at the U.S. FDA for 18 years and also served as the co-editor of FDA’s Investigations Operations Manual (IOM).