This course provides a comprehensive examination of 21 CFR Part 11 the FDA regulation governing electronic records and electronic signatures in all FDA-regulated industries. Originally published in 1997 and last amended in March 2023, Part 11 establishes the criteria under which FDA considers electronic records and electronic signatures to be trustworthy, reliable, and legally equivalent to paper records and handwritten signatures.

The course covers the scope of Part 11 and when it applies including the critical distinction between open and closed systems. All key definitions in §11.3 are examined: electronic record, electronic signature, digital signature, biometrics, open system and closed system.

The 11 mandatory controls for closed systems under §11.10 are covered in full including system validation, the generation of accurate copies, record protection, access limitation, audit trails, operational and authority checks, device checks, personnel qualification, written accountability policies, and system documentation controls. Particular emphasis is placed on §11.10(e) audit trail requirements the most frequently cited Part 11 finding in FDA warning letters including what must be captured, what must not happen to original data, retention requirements, and FDA inspection access rights.

Additional controls required for open systems under §11.30 are addressed, including document encryption and digital signature standards. Signature manifestation requirements (§11.50) and 

signature/record linking (§11.70) are examined in full, along with the three core electronic signature requirements of §11.100uniqueness, identity verification, and non-repudiation certification to FDA. The two-component authentication requirements and biometric signature controls of §11.200, and the five password management controls of §11.300, are covered in detail.

The course concludes with a dedicated slide mapping Part 11 requirements to their corresponding 21 CFR §211.68 CGMP counterparts demonstrating how violations of Part 11 frequently constitute simultaneous data integrity violations under CGMP.

Suitable for: IT and CSV teams, QA managers, regulatory affairs, laboratory personnel, manufacturing operations, and all personnel involved in implementing, validating, or using computerized systems for FDA-regulated records and signatures.

Approx. 35 minutes | 5 assessment questions | Certificate on completion

Source: 21 CFR Part 11, eCFR, last amended 2 March 2023 | ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11