21 CFR Part 11

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation established by the United States Food and Drug Administration (FDA). It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It is commonly used by FDA-regulated industries, such as pharmaceutical, biotechnology, medical device, and food companies, to ensure the integrity and reliability of electronic data used in research, development, manufacturing, and quality control processes. Compliance with 21 CFR Part 11 is essential for these companies to gain FDA approval for their products and avoid regulatory issues.