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Ms access db risk assessment and validation


If I develop an application for example a CAPA application or an adverse reaction report ‎form using Microsoft access can I say that ms access is a configurable package ‎‎(GAMP category 4) and if I add any code in VBA then only that code should be ‎treated as category 5 (code review) or alternatively would ‎only black box testing the application for functionality and part 11 be sufficient ? ‎

Oded ‎

First question, why would you want to do this when there are 3-4 good CAPA applications on the market already.

Would you be better off to stay with a paper based system

Hi Frank thanks for asking, your right development of a CAPA application by a ‎pharma company isn’t a smart thing (although I was once asked to validate a CAPA ‎application that was developed in house). My question isn’t really about development ‎of a Microsoft Access application for CAPA, it can be for Clinical trial management ‎or any other application that is required to be CFR Part 11 compatible. What I try to ‎understand is would black box testing be sufficient for such an application or do I ‎have to do code review and prepare full design documents (FS, DS etc.). ‎