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Remediation strategy for spreadsheet?


I am involved in a spreadsheet validation project, and the assessment has already been done, resulting in a few GxP spreadsheets in the scope. The problem is that most of those spreadsheets contain macros and that there is a lot of critical data transfer involved. It seems simple to me to validate independent and “macroless” spreadsheets, but in this case, I don’t know exactly what strategy to adopt to make them Part 11 compliant (add-on software? if so, which one?). Does anybody have an idea on this or already performed a validation on such spreadsheets?

Thanks for your answers!!!

Have a read of this link


Also this link may help in realtion to add-on software


The fact that they contain macros or not if you have GxP data they still need to be validated for part 11 compliance.

We have performed this type of validation many times with Premier Validation using our own small systems validation template.