TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vsMARS-E

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

26
Controls Mapped
0
Gaps Found
46%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to MARS-E with 46% coverage across 11 directly mapped controls. Analysis of 24 FDA 21 CFR Part 11 controls identifies 13 compliance gaps — primarily concentrated in FDA 21 CFR Part 11: Organizational Requirements.

Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 20 of 26 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

FDA 21 CFR Part 11: Patient Data Protection(14 mappings)

FDA-CFR11-01ePHI access controls and authorization3 targets
→MARSE-01ePHI access controls and authorization
→MARSE-08Information access management
→MARSE-17Facility access controls
FDA-CFR11-02ePHI encryption at rest and in transit5 targets
→MARSE-01ePHI access controls and authorization
→MARSE-02ePHI encryption at rest and in transit
→MARSE-04Patient data de-identification procedures
→MARSE-05Audit trail for ePHI access
→MARSE-16Transmission security and encryption
FDA-CFR11-04Patient data de-identification procedures3 targets
→MARSE-01ePHI access controls and authorization
→MARSE-04Patient data de-identification procedures
→MARSE-05Audit trail for ePHI access
FDA-CFR11-05Audit trail for ePHI access3 targets
→MARSE-01ePHI access controls and authorization
→MARSE-04Patient data de-identification procedures
→MARSE-05Audit trail for ePHI access

FDA 21 CFR Part 11: Administrative Safeguards(6 mappings)

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

+6 more mappings

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Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs NIS2 Directive Implementing Acts11 mappingsFDA 21 CFR Part 11 vs UK Telecommunications (Security) Act 202111 mappingsFDA 21 CFR Part 11 vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule11 mappingsFDA 21 CFR Part 11 vs NIST SP 800-6611 mappingsFDA 21 CFR Part 11 vs TISAX — Trusted Information Security Assessment Exchange11 mappingsFDA 21 CFR Part 11 vs ISO 2779911 mappingsFDA 21 CFR Part 11 vs ISO 1348511 mappingsFDA 21 CFR Part 11 vs GLI-33 — Gaming Laboratories International Event Wagering Systems11 mappings

Other MARS-E comparisons

GLI-33 — Gaming Laboratories International Event Wagering Systems vs MARS-E11 mappingsTISAX — Trusted Information Security Assessment Exchange vs MARS-E11 mappingsISO 13485 vs MARS-E11 mappingsUS Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule vs MARS-E11 mappingsNIS2 Directive Implementing Acts vs MARS-E11 mappingsUK Telecommunications (Security) Act 2021 vs MARS-E11 mappingsISO 27799 vs MARS-E11 mappingsMDS2 (Medical Device) vs MARS-E11 mappings

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What are the key differences between FDA 21 CFR Part 11 and MARS-E?

FDA 21 CFR Part 11 has 24 controls across its framework, while MARS-E covers 24 controls. Direct mapping analysis identifies 11 overlapping controls (46% coverage). The frameworks diverge most significantly in FDA 21 CFR Part 11: Organizational Requirements, where 4 FDA 21 CFR Part 11 controls have no direct MARS-E equivalent.

How many controls map between FDA 21 CFR Part 11 and MARS-E?

Of 24 total FDA 21 CFR Part 11 controls, 11 map directly to MARS-E controls — representing 46% coverage. The remaining 13 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 MARS-E?

13 FDA 21 CFR Part 11 controls have no direct equivalent in MARS-E. The highest concentration of gaps is in FDA 21 CFR Part 11: 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 FDA 21 CFR Part 11 and MARS-E?

The domain with the highest gap count is FDA 21 CFR Part 11: 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

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.