Understanding the Impact of 21 CFR Part 11 on Your Organization

21 CFR Part 11 is the legal framework that controls how businesses handle their electronic documents and signatures. To comply with the FDA’s statutory inspection requirements, the regulation develops a framework for managing records and electronic signatures, making them generally similar to paper archives and handwritten signings completed on paper.

Here, we’ll be taking a deeper look at the impact of 21 CFR Part 11 on a typical organization, and see what requirements should be met.

The Need for 21 CFR Part 11