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Cross-Framework Mapping

FDA 21 CFR Part 11vsUS Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule

See exactly how FDA 21 CFR Part 11 controls map to US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule. 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 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule 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(10 mappings)

FDA-CFR11-01ePHI access controls and authorization3 targets
→314.4(c)(1)Access controls
→HIPAA-164.308(a)(4)Information access management
→HIPAA-164.312(a)(1)Access control
FDA-CFR11-02ePHI encryption at rest and in transit3 targets
→314.4(c)(3)Encryption requirements
→314.4(c)(6)Data disposal procedures
→NYDFS-500.15Encryption of Nonpublic Information
FDA-CFR11-04Patient data de-identification procedures
→314.4(c)(6)Data disposal procedures
FDA-CFR11-05Audit trail for ePHI access3 targets
→314.4(c)(6)Data disposal procedures
→314.4(c)(8)Monitoring and logging
→NYDFS-500.14Monitoring and Logging

FDA 21 CFR Part 11: Administrative Safeguards(8 mappings)

FDA-CFR11-06Security management process and risk analysis2 targets
→314.4(b)Written risk assessment
→314.4(d)Continuous monitoring and testing
FDA-CFR11-07Workforce security and clearance procedures
→HIPAA-164.308(a)(3)Workforce security
FDA-CFR11-08Information access management3 targets
→314.4(c)(1)Access controls
→HIPAA-164.308(a)(4)Information access management
→HIPAA-164.312(a)(1)Access control
FDA-CFR11-09Security awareness and training program2 targets
→314.4(e)Security awareness training
→HIPAA-164.308(a)(5)Security awareness and training

FDA 21 CFR Part 11: Technical Safeguards(2 mappings)

FDA-CFR11-12Unique user identification and authentication2 targets
→314.4(c)(5)Multi-factor authentication
→HIPAA-164.312(d)Person or entity authentication

+6 more mappings

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Related Comparisons

Other FDA 21 CFR Part 11 comparisons

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Other US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule comparisons

CSA CCM v4 vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule21 mappingsFAA Cybersecurity Framework for Aviation vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule21 mappingsTISAX — Trusted Information Security Assessment Exchange vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule21 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule20 mappingsFTC Safeguards Rule (16 CFR Part 314) vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule20 mappingsNYDFS Cybersecurity Regulation (23 NYCRR Part 500) vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule20 mappingsPAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule20 mappingsNew Zealand Information Security Manual (NZISM) vs US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule20 mappings

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

FDA 21 CFR Part 11 has 24 controls across its framework, while US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule covers 41 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 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule equivalent.

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

Of 24 total FDA 21 CFR Part 11 controls, 11 map directly to US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule 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 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule?

13 FDA 21 CFR Part 11 controls have no direct equivalent in US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule. 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 US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule?

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

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