Question 21 CFR Part 11 Integration!

[vapid2323]

My current project requires that my database complies with 21 CFR Part 11, it is an FDA regulation for GxP projects.

I wanted to know if anyone has experience with this type of project, as this will be my first one.

Any tips on how to develop a database with this in mind?

 

[Rabbie]

A google search seems to indicate that conformance depends on not being able to change data before printing it out. So provided you can restrict users to using the standard Interfaces t should be OK. Of course as with any computer system any expert can produce any desired document.