FDA - 21 CFR

Title 21 Part 11 of the Code of Federal Regulations (CFR) deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. The rules for this policy are:

• FDA 21 CFR: Clinical Trials
• FDA 21 CFR: Controlled Drugs
• FDA 21 CFR: DICOM
• FDA 21 CFR: DNA Sequence
• FDA 21 CFR: Name and Common Medical Condition (Default)
• FDA 21 CFR: Name and Common Medical Condition (Narrow)
• FDA 21 CFR: Password Dissemination for HTTP Traffic (Wide)
• FDA 21 CFR: Password Dissemination for HTTP Traffic (Default)
• FDA 21 CFR: Password Dissemination for HTTP Traffic (Narrow)
• FDA 21 CFR: Protein Sequence (Default)
• FDA 21 CFR: Protein Sequence (Narrow)