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Cross-Framework Mapping

FDA 21 CFR Part 11vsNIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)

See exactly how FDA 21 CFR Part 11 controls map to NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI). Pre-computed mappings, identified gaps, and coverage analysis.

18
Controls Mapped
0
Gaps Found
38%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) with 38% coverage across 5 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 8 compliance gaps — primarily concentrated in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)).

Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 18 of 18 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(3 mappings)

Part11.10Controls for closed systems (21 CFR §11.10)3 targets
→171A-AT-01Assess Security Awareness Training
→171A-AT-02Assess Role-Based Security Training
→171A-IA-02Assess Multi-Factor Authentication

21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(4 mappings)

Part11.30Controls for open systems (21 CFR §11.30)4 targets
→171A-AC-07Assess Wireless Access Controls
→171A-MP-01Assess Media Protection
→171A-SC-02Assess Cryptographic Protection
→171A-SC-03Assess Communications Protection

21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(3 mappings)

Part11.300Controls for identification codes and passwords (21 CFR §11.300)3 targets
→171A-AC-06Assess Remote Access Controls
→171A-AC-07Assess Wireless Access Controls
→171A-IA-01Assess Identification and Authentication

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(8 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))5 targets
→171A-AC-02Assess Access Enforcement
→171A-AC-04Assess Separation of Duties
→171A-AC-05Assess Least Privilege
→171A-AC-06Assess Remote Access Controls
→171A-IA-02Assess Multi-Factor Authentication
Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))3 targets
→171A-AU-02Assess Audit Record Review and Reporting
→171A-AU-03Assess Audit Record Protection
→171A-AU-04Assess Audit Record Retention

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems9 mappingsFDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 mappingsFDA 21 CFR Part 11 vs Azure Security Benchmark6 mappingsFDA 21 CFR Part 11 vs AWS Well-Architected Security Pillar6 mappingsFDA 21 CFR Part 11 vs ASD Strategies to Mitigate Cyber Security Incidents6 mappingsFDA 21 CFR Part 11 vs CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.06 mappingsFDA 21 CFR Part 11 vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)5 mappingsFDA 21 CFR Part 11 vs Privacy Act 1988 (Australia)5 mappings

Other NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) comparisons

NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)22 mappingsNIST Privacy Framework vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)21 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)20 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)20 mappingsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)20 mappingsSLSA vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)19 mappingsSIG (Shared Assessments) vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)19 mappingsPTES vs NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)19 mappings

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What are the key differences between FDA 21 CFR Part 11 and NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)?

FDA 21 CFR Part 11 has 13 controls across its framework, while NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) covers 32 controls. Direct mapping analysis identifies 5 overlapping controls (38% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 2 FDA 21 CFR Part 11 controls have no direct NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) equivalent.

How many controls map between FDA 21 CFR Part 11 and NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)?

Of 13 total FDA 21 CFR Part 11 controls, 5 map directly to NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) controls — representing 38% coverage. The remaining 8 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 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)?

8 FDA 21 CFR Part 11 controls have no direct equivalent in NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI). The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 2 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 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)?

The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (2 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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