What Is 21 CFR Part 11 Compliance?

21 CFR Part 11 is a ruling from the Food and Drug Administration (FDA). This ruling states how electronic records and signatures can be substituted for paper documents and handwritten signatures. 

21 CFR Part 11 compliance is important in the life sciences industry. 

How Does 21 CFR Part 11 Impact Product Development?

If you develop products (like medical devices), you're likely impacted by 21 CFR Part 11. 

In this white paper, you'll learn:

  • How 21 CFR Part 11 impacts product development.
  • Which requirements you need to comply with.
  • What you need to create a 21 CFR Part 11 compliance matrix.

Additional Resources for Compliance

Interested in learning more about compliance in product development? Explore the following resources: