21 CFR Part 11 is a set of regulations issued by the United States Food and Drug Administration (FDA) that establishes the criteria for electronic records and electronic signatures (ERES) used in the pharmaceutical and medical device industries. The regulations are intended to ensure the accuracy, integrity, and security of electronic records and signatures used in the maintenance of medical records and other regulated activities. The regulations also provide guidance on the use of electronic systems for the maintenance of records and the implementation of electronic signatures. 21 CFR Part 11 applies to all organizations that are subject to FDA regulations, including pharmaceutical and medical device manufacturers, distributors, and healthcare providers. The regulations require organizations to implement measures to ensure the accuracy, integrity, and security of electronic records and signatures, including the use of secure authentication methods, audit trails, and other security measures.
