Hello Everyone,
I have a very general question that I hope I can get some insight into. Say you have a Vision project (could relate also to Perspective) that is fully developed as an assembly machine. You have a database already configured for collecting machine/part data (all done through gateway/project scripting) and you have 4 basic roles for login credentials and accessibility (no Active Directory created). How big of a task would it be to add 21 CFR Part 11 functionality into this project. This project would not contain any extra modules, just the base vision license. I only understand 21 CFR Part 11 at a cursorily level, but would have to implement this all myself. This would include learning the requirements, coding the functionality, and modifying already existing components of the project / database to meet all of the GxP requirements. I know this question is very broad, but any insight could be very informative for me.
TIA.
William