Is anyone here in an FDA regulated environment? If so, would you mind sending me a PM? I'd like to pick your brain about your process, compare it to our relatively young one, see if we could learn anything from each other.

If it helps, we are under 21 CFR Part 11, have regulations to follow PIC/S PI011-3, and follow Final Guidance for the Industry and FDA Staff - General Principals of Software Validation.