eQMS
Mastering 21 CFR Part 11 Compliance: The Ultimate Guide
In the life sciences sector, aligning with 21 CFR Part 11 isn’t just good practice—it’s crucial. This regulation, part of the Code of Federal Regulations, ensures the reliability of electronic records and signatures for FDA-regulated entities like pharmaceuticals, medical device manufacturers, and biotech firms. Let’s simplify what this means and how to stay compliant.