21 CFR Part 11 Compliance Solutions:

We know Part 11, understand the FDA’s current Part 11 focus
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. We have aided many companies in understanding the FDA’s current position on Part 11 and how to use risk based strategies to reduce compliance risk. Our checklists ensure focus on the systems that are most likely to be inspected by the FDA.