FDA 21 CFR Part 11vsNIST SP 800-66
See exactly how FDA 21 CFR Part 11 controls map to NIST SP 800-66. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to NIST SP 800-66 with 46% coverage across 11 directly mapped controls. Analysis of 24 FDA 21 CFR Part 11 controls identifies 13 compliance gaps — primarily concentrated in FDA 21 CFR Part 11: Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 25 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
FDA 21 CFR Part 11: Patient Data Protection(13 mappings)
FDA 21 CFR Part 11: Administrative Safeguards(6 mappings)
FDA 21 CFR Part 11: Technical Safeguards(1 mappings)
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Related Comparisons
Other FDA 21 CFR Part 11 comparisons
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What are the key differences between FDA 21 CFR Part 11 and NIST SP 800-66?
FDA 21 CFR Part 11 has 24 controls across its framework, while NIST SP 800-66 covers 24 controls. Direct mapping analysis identifies 11 overlapping controls (46% coverage). The frameworks diverge most significantly in FDA 21 CFR Part 11: Organizational Requirements, where 4 FDA 21 CFR Part 11 controls have no direct NIST SP 800-66 equivalent.
How many controls map between FDA 21 CFR Part 11 and NIST SP 800-66?
Of 24 total FDA 21 CFR Part 11 controls, 11 map directly to NIST SP 800-66 controls — representing 46% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA 21 CFR Part 11 to NIST SP 800-66?
13 FDA 21 CFR Part 11 controls have no direct equivalent in NIST SP 800-66. The highest concentration of gaps is in FDA 21 CFR Part 11: Organizational Requirements with 4 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between FDA 21 CFR Part 11 and NIST SP 800-66?
The domain with the highest gap count is FDA 21 CFR Part 11: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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