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FDA 21 CFR Part 11
21 CFR Part 11 (62 FR 13430 March 20 1997) establishes the criteria under which the FDA considers electronic records + electronic signatures to be trustworthy + reliable + equivalent to paper records + handwritten signatures. The regulation applies to ALL electronic records + signatures created + modified + maintained + archived + retrieved + transmitted under any records requirement set forth in any FDA regulation or any electronic records submitted to FDA under the Federal Food + Drug + and Cosmetic Act + Public Health Service Act + Tobacco Control Act.
Domains
21 CFR Part 11 Subpart C - Electronic Signatures (§11.100 General Requirements)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))
21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions)
21 CFR Part 11 - Implementation, Guidance, Risk-Based Approach and Status
21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)
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Frequently Asked Questions
What is FDA 21 CFR Part 11?
21 CFR Part 11 (62 FR 13430 March 20 1997) establishes the criteria under which the FDA considers electronic records + electronic signatures to be trustworthy + reliable + equivalent to paper records + handwritten signatures. The regulation applies to ALL electronic records + signatures created + modified + maintained + archived + retrieved + transmitted under any records requirement set forth in any FDA regulation or any electronic records submitted to FDA under the Federal Food + Drug + and Cosmetic Act + Public Health Service Act + Tobacco Control Act.
How many controls does FDA 21 CFR Part 11 have?
FDA 21 CFR Part 11 contains 13 controls organized across 7 domains.
Where does FDA 21 CFR Part 11 apply?
FDA 21 CFR Part 11 is applicable in United States. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.
What frameworks does FDA 21 CFR Part 11 map to?
FDA 21 CFR Part 11 has control-to-control mappings with 86 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.
How do I get started with FDA 21 CFR Part 11 compliance?
Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.
How ready are you for FDA 21 CFR Part 11?
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