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Cross-Framework Mapping

NIST SP 800-66vsFDA 21 CFR Part 11

See exactly how NIST SP 800-66 controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

25
Controls Mapped
0
Gaps Found
42%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIST SP 800-66 maps to FDA 21 CFR Part 11 with 42% coverage across 10 directly mapped controls. Analysis of 24 NIST SP 800-66 controls identifies 14 compliance gaps — primarily concentrated in NIST SP 800-66: 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.

NIST SP 800-66: Patient Data Protection(13 mappings)

NIST800-66-01ePHI access controls and authorization6 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
NIST800-66-02ePHI encryption at rest and in transit4 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
→FDA-CFR11-16Transmission security and encryption
NIST800-66-05Audit trail for ePHI access3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access

NIST SP 800-66: Administrative Safeguards(6 mappings)

NIST800-66-06Security management process and risk analysis
→FDA-CFR11-06Security management process and risk analysis
NIST800-66-07Workforce security and clearance procedures
→FDA-CFR11-07Workforce security and clearance procedures
NIST800-66-08Information access management3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
NIST800-66-09Security awareness and training program
→FDA-CFR11-09Security awareness and training program

NIST SP 800-66: Technical Safeguards(1 mappings)

NIST800-66-12Unique user identification and authentication
→FDA-CFR11-12Unique user identification and authentication

+5 more mappings

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Related Comparisons

Other NIST SP 800-66 comparisons

NIST SP 800-66 vs ISO 2779910 mappingsNIST SP 800-66 vs UK Telecommunications (Security) Act 202110 mappingsNIST SP 800-66 vs ISO 1348510 mappingsNIST SP 800-66 vs MARS-E10 mappingsNIST SP 800-66 vs MDS2 (Medical Device)10 mappingsNIST SP 800-66 vs GLI-33 — Gaming Laboratories International Event Wagering Systems10 mappingsNIST SP 800-66 vs TISAX — Trusted Information Security Assessment Exchange10 mappingsNIST SP 800-66 vs NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements10 mappings

Other FDA 21 CFR Part 11 comparisons

NIS2 Directive Implementing Acts vs FDA 21 CFR Part 1111 mappingsUK Telecommunications (Security) Act 2021 vs FDA 21 CFR Part 1111 mappingsUS Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule vs FDA 21 CFR Part 1111 mappingsTISAX — Trusted Information Security Assessment Exchange vs FDA 21 CFR Part 1111 mappingsISO 27799 vs FDA 21 CFR Part 1111 mappingsISO 13485 vs FDA 21 CFR Part 1111 mappingsGLI-33 — Gaming Laboratories International Event Wagering Systems vs FDA 21 CFR Part 1111 mappingsMDS2 (Medical Device) vs FDA 21 CFR Part 1111 mappings

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What are the key differences between NIST SP 800-66 and FDA 21 CFR Part 11?

NIST SP 800-66 has 24 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 10 overlapping controls (42% coverage). The frameworks diverge most significantly in NIST SP 800-66: Organizational Requirements, where 4 NIST SP 800-66 controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between NIST SP 800-66 and FDA 21 CFR Part 11?

Of 24 total NIST SP 800-66 controls, 10 map directly to FDA 21 CFR Part 11 controls — representing 42% coverage. The remaining 14 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIST SP 800-66 to FDA 21 CFR Part 11?

14 NIST SP 800-66 controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in NIST SP 800-66: 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 NIST SP 800-66 and FDA 21 CFR Part 11?

The domain with the highest gap count is NIST SP 800-66: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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