Learnaboutgmp Community

Querys

Hello all,
I need to know briefly the main points to assess the compliance whether or not a system

according to 21 CFR Part 11. On the other hand: Which are the direct links to Predicate

Rules and Preamble of the FDA.

Thanks very much!!
carlos

We have a part 11 template if you need a copy

http://www.askaboutvalidation.com/kits_expanded.php?uid=43