TheArtOfService
Cross-Framework Mapping

Belgium CyberFundamentalsvsFDA 21 CFR Part 11

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

18
Controls Mapped
14
Gaps Found
34%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Belgium CyberFundamentals maps to FDA 21 CFR Part 11 with 34% coverage across 11 directly mapped controls. Analysis of 32 Belgium CyberFundamentals controls identifies 21 compliance gaps — primarily concentrated in Belgium CyberFundamentals: Incident Response.

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

Control Mappings

Showing 18 of 18 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Belgium CyberFundamentals: Access Control & Identity(10 mappings)

BE-CF-01Account management and provisioning3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
BE-CF-02Access enforcement and least privilege3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
BE-CF-03Multi-factor authentication requirements
→FDA-CFR11-12Unique user identification and authentication
BE-CF-06Identity proofing and verification3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls

Belgium CyberFundamentals: System & Communications Protection(2 mappings)

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

Belgium CyberFundamentals: Risk Assessment & Management(3 mappings)

BE-CF-13Risk assessment procedures
→FDA-CFR11-06Security management process and risk analysis
BE-CF-15Security categorization
→FDA-CFR11-06Security management process and risk analysis
BE-CF-17Continuous monitoring strategy
→FDA-CFR11-06Security management process and risk analysis

Belgium CyberFundamentals: Audit & Accountability(3 mappings)

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

Related 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 Belgium CyberFundamentals and FDA 21 CFR Part 11?

Belgium CyberFundamentals has 32 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 11 overlapping controls (34% coverage). The frameworks diverge most significantly in Belgium CyberFundamentals: Incident Response, where 5 Belgium CyberFundamentals controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between Belgium CyberFundamentals and FDA 21 CFR Part 11?

Of 32 total Belgium CyberFundamentals controls, 11 map directly to FDA 21 CFR Part 11 controls — representing 34% coverage. The remaining 21 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Belgium CyberFundamentals to FDA 21 CFR Part 11?

21 Belgium CyberFundamentals controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Belgium CyberFundamentals: Incident Response 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 Belgium CyberFundamentals and FDA 21 CFR Part 11?

The domain with the highest gap count is Belgium CyberFundamentals: Incident Response (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.