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FDA 21 CFR Part 11

What is FDA 21 CFR Part 11?

US FDA regulations establishing criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures.

Compliance and Regulatory

Terms that appear alongside fda 21 cfr part 11

Each of these is named in at least one of the same controls as fda 21 cfr part 11. The number is how many controls name both.

Frameworks that govern fda 21 cfr part 11

HIPAA Security RuleView framework →ISO 27001:2022View framework →NIST Cybersecurity Framework 2.0View framework →

What the standards actually require on fda 21 cfr part 11

Requirements naming fda 21 cfr part 11 across 3 standards, quoted from the control text.

GAMP 5 - Good Automated Manufacturing Practice2 controls

GAMP 5 DATA INTEGRITY + 21 CFR PART 11 + EU ANNEX 11 alignment. ALCOA+ PRINCIPLES (FDA + EMA + MHRA Data Integrity Guidance): ATTRIBUTABLE + LEGIBLE + CONTEMPORANEOUS + ORIGINAL + ACCURATE + COMPLETE + CONSISTENT + ENDURING + AVAILABLE.

GAMP5-DataIntegrity-Part11-Annex11 · Data Integrity (ALCOA+), 21 CFR Part 11 + EU Annex 11 + Electronic Records →
FDA Quality Management System Regulation (QMSR)1 control

Section 820.35 establishes FDA-specific record-control requirements that supplement ISO 13485:2016 Section 4.2.5. SPECIFIC REQUIREMENTS: (a) RECORD RETENTION - records must be retained for a period of time equivalent to the design + expected life of the device...

QMSR-820.35 · Control of records - record retention, audit trail, UDI, medical-device reporting (§820.35) →
ICH E6(R3) - Good Clinical Practice1 control

ICH E6(R3) Annex 1 (Computer Systems Used in Clinical Trials) is the new section consolidating data integrity + electronic systems + computer system validation (CSV) - replacing scattered E6(R2) provisions.

ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrity · ICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity →

Questions people ask about fda 21 cfr part 11

What is FDA 21 CFR Part 11?
US FDA regulations establishing criteria for accepting electronic records and electronic signatures as equivalent to paper records and handwritten signatures.
Why is FDA 21 CFR Part 11 important for compliance?
FDA 21 CFR Part 11 is a key concept in Compliance and Regulatory. Understanding fda 21 cfr part 11 helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 686 frameworks with 311K cross-framework control mappings.
Which compliance frameworks address FDA 21 CFR Part 11?
FDA 21 CFR Part 11 appears in the requirement text of GAMP 5 - Good Automated Manufacturing Practice, FDA Quality Management System Regulation (QMSR), ICH E6(R3) - Good Clinical Practice. Across these standards we have identified 4 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about FDA 21 CFR Part 11?
Explore our compliance framework pages to see how fda 21 cfr part 11 applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 686 frameworks.

See how FDA 21 CFR Part 11 applies across compliance frameworks

Our platform maps 686 frameworks with 311K cross-framework control mappings. Explore how this concept is addressed across standards.

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Written and maintained by Gerard Blokdyk, The Art of Service.