TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vsAPI 1164

See exactly how FDA 21 CFR Part 11 controls map to API 1164. Pre-computed mappings, identified gaps, and coverage analysis.

9
Controls Mapped
4
Gaps Found
15%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to API 1164 with 15% coverage across 2 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 11 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 | 330K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(9 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))6 targets
→API1164-06Access Control
→API1164-06Access Control
→API1164-07Remote Access
→API1164-07Remote Access
→API1164-09Patch and Vulnerability Management
→API1164-09Patch and Vulnerability Management
Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)3 targets
→API1164-07Remote Access
→API1164-07Remote Access
→API1164-24Vulnerability assessment for critical systems

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

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Other API 1164 comparisons

NIST SP 800-53 Rev 5 vs API 116422 mappingsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs API 116417 mappingsNIS2 Directive vs API 116416 mappingsIEEE 1686 vs API 116416 mappingsIEC 62443 vs API 116416 mappingsNIST SP 1800-32 vs API 116416 mappingsISO 27019 vs API 116416 mappingsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs API 116413 mappings

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What are the key differences between FDA 21 CFR Part 11 and API 1164?

FDA 21 CFR Part 11 has 13 controls across its framework, while API 1164 covers 24 controls. Direct mapping analysis identifies 2 overlapping controls (15% 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 API 1164 equivalent.

How many controls map between FDA 21 CFR Part 11 and API 1164?

Of 13 total FDA 21 CFR Part 11 controls, 2 map directly to API 1164 controls — representing 15% coverage. The remaining 11 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 API 1164?

11 FDA 21 CFR Part 11 controls have no direct equivalent in API 1164. 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 API 1164?

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

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.