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Cross-Framework Mapping

US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards RulevsFDA 21 CFR Part 11

See exactly how US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

26
Controls Mapped
15
Gaps Found
39%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule maps to FDA 21 CFR Part 11 with 39% coverage across 16 directly mapped controls. Analysis of 41 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule controls identifies 25 compliance gaps — primarily concentrated in Administrative Safeguards.

Source: TheArtOfService Knowledge Graph | 41 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.

Programme Governance(1 mappings)

314.4(b)Written risk assessment
→FDA-CFR11-06Security management process and risk analysis

Technical Safeguards(15 mappings)

314.4(c)(1)Access controls3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
314.4(c)(3)Encryption requirements2 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-16Transmission security and encryption
314.4(c)(5)Multi-factor authentication
→FDA-CFR11-12Unique user identification and authentication
314.4(c)(8)Monitoring and logging
→FDA-CFR11-05Audit trail for ePHI access
HIPAA-164.312(a)(1)Access control3 targets
→FDA-CFR11-01ePHI access controls and authorization
→FDA-CFR11-08Information access management
→FDA-CFR11-17Facility access controls
HIPAA-164.312(d)Person or entity authentication
→FDA-CFR11-12Unique user identification and authentication
NYDFS-500.12Multi-Factor Authentication
→FDA-CFR11-12Unique user identification and authentication
NYDFS-500.14Monitoring and Logging
→FDA-CFR11-05Audit trail for ePHI access
NYDFS-500.15Encryption of Nonpublic Information2 targets
→FDA-CFR11-02ePHI encryption at rest and in transit
→FDA-CFR11-16Transmission security and encryption

Administrative Safeguards(4 mappings)

314.4(c)(6)Data disposal 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
314.4(e)Security awareness training
→FDA-CFR11-09Security awareness and training program

+6 more mappings

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Related Comparisons

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Other FDA 21 CFR Part 11 comparisons

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What are the key differences between US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule and FDA 21 CFR Part 11?

US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule has 41 controls across its framework, while FDA 21 CFR Part 11 covers 24 controls. Direct mapping analysis identifies 16 overlapping controls (39% coverage). The frameworks diverge most significantly in Administrative Safeguards, where 9 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule and FDA 21 CFR Part 11?

Of 41 total US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule controls, 16 map directly to FDA 21 CFR Part 11 controls — representing 39% coverage. The remaining 25 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule to FDA 21 CFR Part 11?

25 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Administrative Safeguards with 9 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 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule and FDA 21 CFR Part 11?

The domain with the highest gap count is Administrative Safeguards (9 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

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