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 §11.100

uniqueness, 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