Breakdown Of The Basics: 21 CFR Part 11 and Annex 11

Three Fundamental Elements of Both 21 CFR Part 11 and Annex 11

Along with providing monitoring and validation systems, we often delve into issues that arise for our customers when they are interpreting regulations and guidance. We receive many questions on 21 CFR Part 11 and Annex 11.  In this article we we offer some background and a brief overview of three focal points of both of the "Elevens"  including:  System Controls, Validation and Archiving.

It's important to note that Part 11 is a requirement in the US, whereas Annex 11, which applies to the EU, is a guidance document only. By the way, we are assured by those in the know that the "11" in the titles are  incidental. Someone please correct us if we've been misinformed!