What is 21 CFR Part 11?

Title 21 CFR Part 11 is the part of the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures for Life Sciences.

You can read the text of 21 CFR Part 11 here.

MSB has special requirements in place to ensure compliance with 21 CFR Part 11, when you use our Signature 21 CFR signing policy. And for our Life Science clients, we provide a fully validated system which includes objective evidence. Contact our Sales Team at sales@msbdocs.com to learn more.

Updated on: 08/22/2023