21 CFR Part 11 (Electronic Records and Signatures)

21 CFR Part 11 is the FDA regulation establishing the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. It is the rule that any PLM, QMS, EBR, or LIMS system must satisfy when its records replace paper for FDA-regulated products.

Scope

Part 11 imposes requirements for system validation, audit trails, record retention, copies of records, training, accountability, controls for closed and open systems, signature manifestations (printed name, date/time, meaning), signature/record linking, and biometric/non-biometric signature controls. Applicability and enforcement discretion are described further in the FDA’s Part 11 Scope and Application guidance (2003) which most pharma and device manufacturers use as the baseline interpretation.

Relationships (see sidebar)

• Normative for the Document Vault, Workflow Engine (e-signatures), QMS capability, and the medical-device records DHF / DMR / DHR.
• Companion to 21 CFR Part 820 for medical devices and to GxP regimes for pharma.

Steward

US Food and Drug Administration (FDA).