Hi,
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.).