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Cross-Framework Mapping

ANSSI Cybersecurity FrameworkvsFDA 21 CFR Part 11

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

19
Controls Mapped
13
Gaps Found
38%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ANSSI Cybersecurity Framework maps to FDA 21 CFR Part 11 with 38% coverage across 12 directly mapped controls. Analysis of 32 ANSSI Cybersecurity Framework controls identifies 20 compliance gaps — primarily concentrated in ANSSI Cybersecurity Framework: Configuration Management.

Source: TheArtOfService Knowledge Graph | 32 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 19 of 19 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

ANSSI Cybersecurity Framework: Access Control & Identity(11 mappings)

ANSSI-02Access enforcement and least privilege
→FDA-CFR11-01ePHI access controls and authorization
ANSSI-03Multi-factor authentication requirements
→FDA-CFR11-12Unique user identification and authentication
ANSSI-04Remote access controls3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
ANSSI-05Wireless access restrictions3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
ANSSI-06Identity proofing and verification3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls

ANSSI Cybersecurity Framework: System & Communications Protection(2 mappings)

ANSSI-08Cryptographic protection of data2 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-16Transmission security and encryption

ANSSI Cybersecurity Framework: Risk Assessment & Management(3 mappings)

ANSSI-14Vulnerability scanning and management
→FDA-CFR11-06Security management process and risk analysis
ANSSI-16Threat intelligence integration
→FDA-CFR11-06Security management process and risk analysis
ANSSI-17Continuous monitoring strategy
→FDA-CFR11-06Security management process and risk analysis

ANSSI Cybersecurity Framework: Audit & Accountability(3 mappings)

ANSSI-28Audit event logging and storage
→FDA-CFR11-05Audit trail for ePHI access
ANSSI-29Audit record review and analysis
→FDA-CFR11-05Audit trail for ePHI access
ANSSI-31Audit log protection and retention
→FDA-CFR11-05Audit trail for ePHI access

Related Comparisons

Other ANSSI Cybersecurity Framework comparisons

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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 mappingsNIST SP 800-66 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 mappings

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What are the key differences between ANSSI Cybersecurity Framework and FDA 21 CFR Part 11?

ANSSI Cybersecurity Framework has 32 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 12 overlapping controls (38% coverage). The frameworks diverge most significantly in ANSSI Cybersecurity Framework: Configuration Management, where 5 ANSSI Cybersecurity Framework controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between ANSSI Cybersecurity Framework and FDA 21 CFR Part 11?

Of 32 total ANSSI Cybersecurity Framework controls, 12 map directly to FDA 21 CFR Part 11 controls — representing 38% coverage. The remaining 20 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ANSSI Cybersecurity Framework to FDA 21 CFR Part 11?

20 ANSSI Cybersecurity Framework controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in ANSSI Cybersecurity Framework: Configuration Management with 5 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 ANSSI Cybersecurity Framework and FDA 21 CFR Part 11?

The domain with the highest gap count is ANSSI Cybersecurity Framework: Configuration Management (5 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.