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!!!