TheArtOfService
Cross-Framework Mapping

MARS-EvsFDA 21 CFR Part 11

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

26
Controls Mapped
37
Gaps Found
17%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

MARS-E maps to FDA 21 CFR Part 11 with 17% coverage across 11 directly mapped controls. Analysis of 63 MARS-E controls identifies 52 compliance gaps — primarily concentrated in Access Control.

Source: TheArtOfService Knowledge Graph | 63 controls analysed | 724 frameworks | 440K+ cross-framework mappings

Control Mappings

Showing 20 of 26 mapped controls across 4 domains. Sign up to explore all 440K+ mappings across 724 frameworks.

MARS-E: Patient Data Protection(14 mappings)

MARSE-01ePHI access controls and authorization6 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
MARSE-02ePHI encryption at rest and in transit2 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-16Transmission security and encryption
MARSE-04Patient data de-identification procedures3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access
MARSE-05Audit trail for ePHI access3 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-04Patient data de-identification procedures
→FDA-CFR11-05Audit trail for ePHI access

MARS-E: Administrative Safeguards(6 mappings)

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

+6 more mappings

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Related Comparisons

Other MARS-E comparisons

MARS-E vs ISO 1348511 mappingsMARS-E vs ISO 2779911 mappingsMARS-E vs MDS2 (Medical Device)11 mappingsMARS-E vs TISAX - Trusted Information Security Assessment Exchange11 mappingsMARS-E vs NIST SP 800-6611 mappingsMARS-E vs NIST SP 800-53 Rev 510 mappingsMARS-E vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements10 mappingsMARS-E vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)10 mappings

Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 1120 mappingsISO 13485 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 mappingsMDS2 (Medical Device) vs FDA 21 CFR Part 1111 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs FDA 21 CFR Part 1110 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 1110 mappings

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

MARS-E has 63 controls across its framework, while FDA 21 CFR Part 11 covers 57 controls. Direct mapping analysis identifies 11 overlapping controls (17% coverage). The frameworks diverge most significantly in Access Control, where 5 MARS-E controls have no direct FDA 21 CFR Part 11 equivalent.

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

Of 63 total MARS-E controls, 11 map directly to FDA 21 CFR Part 11 controls — representing 17% coverage. The remaining 52 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping MARS-E to FDA 21 CFR Part 11?

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

The domain with the highest gap count is Access Control (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.