21 CFR Part 11

21 CFR Part 11 states when electronic records and electronic signatures are trustworthy enough for FDA to treat them as equivalent to paper records and handwritten signatures.

The rule covers systems that create, modify, maintain, archive, retrieve or transmit electronic records required by other FDA regulations. Controls include validation, readable copies, protection of records, limiting access, audit trails for some changes, and, for signatures, uniqueness, verification of identity, and a clear meaning of the signature. Part 11 applies when you choose electronic records to meet a predicate rule. It is not a general IT certificate.

A practical reading for an eQMS is: unique user accounts, authority checks, a trail of who approved a record and when, and signatures that cannot be casually copied. The 2003 FDA scope and application guidance narrowed enforcement discretion for some audit-trail and validation topics. Read it before you gold-plate a low-risk form, and do not use it to skip controls on records you truly rely on.

HAVGATE document approval and audit-report approval use electronic signatures the product describes as Part 11 compliant. Your validation decides where you rely on them. See the document control page and the security page for access and encryption statements.