Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations establishing the US Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Most commonly referred to as Part 11, it establishes the criteria for trustworthy and reliable electronic records and electronic signatures.
Part 11 compliance is particularly important in clinical trials because it applies to drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and Research Sites. To comply with regulations, companies involved in clinical trials must implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data that FDA predicate rules require them to maintain.
Because of the complexity of rules and regulations surrounding Title 21 CFR Part 11 over the years, the FDA has released, in addition to formal regulations, informal guidance on how to best comply with the requirements.
Florence has deep experience and knowledge with compliance and works with each client to ensure FDA Part 11 compliance.
Additionally, Florence has developed an in-depth guide to eRegulatory and eSource compiled from over 150 questions and answers by the FDA.