TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vs3GPP 5G Security Architecture (TS 33.501)

See exactly how FDA 21 CFR Part 11 controls map to 3GPP 5G Security Architecture (TS 33.501). Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
50
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to 3GPP 5G Security Architecture (TS 33.501) with 7% coverage across 4 directly mapped controls. Analysis of 57 FDA 21 CFR Part 11 controls identifies 53 compliance gaps — primarily concentrated in Electronic Signature.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 725 frameworks | 447K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 2 domains. Sign up to explore all 447K+ mappings across 725 frameworks.

FDA 21 CFR Part 11: Patient Data Protection(4 mappings)

FDA-CFR11-01ePHI access controls and authorization2 targets
→TS33.501-13.1NF Registration and Discovery Security
→TS33.501-13.4OAuth 2.0 Authorization Framework
FDA-CFR11-02ePHI encryption at rest and in transit2 targets
→TS33.501-13.2NF Service Authorization
→TS33.501-6.6AS Security

FDA 21 CFR Part 11: Technical Safeguards(3 mappings)

FDA-CFR11-12Unique user identification and authentication
→TS33.501-6.1Authentication Framework
FDA-CFR11-16Transmission security and encryption2 targets
→TS33.501-13.2NF Service Authorization
→TS33.501-6.6AS Security

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems20 mappingsFDA 21 CFR Part 11 vs ISO 1348511 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 MDS2 (Medical Device)11 mappingsFDA 21 CFR Part 11 vs MARS-E11 mappingsFDA 21 CFR Part 11 vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements10 mappings

Other 3GPP 5G Security Architecture (TS 33.501) comparisons

NIST SP 800-53 Rev 5 vs 3GPP 5G Security Architecture (TS 33.501)38 mappingsNIST SP 800-187 vs 3GPP 5G Security Architecture (TS 33.501)22 mappingsOWASP SAMM vs 3GPP 5G Security Architecture (TS 33.501)5 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs 3GPP 5G Security Architecture (TS 33.501)5 mappingsAzure Security Benchmark vs 3GPP 5G Security Architecture (TS 33.501)5 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs 3GPP 5G Security Architecture (TS 33.501)5 mappingsBSI IT-Grundschutz vs 3GPP 5G Security Architecture (TS 33.501)5 mappingsNIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) vs 3GPP 5G Security Architecture (TS 33.501)5 mappings

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 725 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 725 framework browser
  • ✓ Cross-framework mappings (447K+)
  • ✓ 824 compliance assessments
  • ✓ 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • ✓ Unlimited AI Compliance Advisory
  • ✓ Unlimited full-text search
  • ✓ Framework self-assessment
  • ✓ PDF, Excel & CSV exports
Start 7-Day Free Trial →

Popular framework comparisons

NIST CSF vs NIST 800-53ISO 27001 vs NIST CSFCMMC vs NIST 800-53FedRAMP vs NIST 800-53NIST CSF vs SOC 2HIPAA vs NIST 800-53ISO 27001 vs SOC 2ISO 27001 vs ISO 27701

What are the key differences between FDA 21 CFR Part 11 and 3GPP 5G Security Architecture (TS 33.501)?

FDA 21 CFR Part 11 has 57 controls across its framework, while 3GPP 5G Security Architecture (TS 33.501) covers 43 controls. Direct mapping analysis identifies 4 overlapping controls (7% coverage). The frameworks diverge most significantly in Electronic Signature, where 16 FDA 21 CFR Part 11 controls have no direct 3GPP 5G Security Architecture (TS 33.501) equivalent.

How many controls map between FDA 21 CFR Part 11 and 3GPP 5G Security Architecture (TS 33.501)?

Of 57 total FDA 21 CFR Part 11 controls, 4 map directly to 3GPP 5G Security Architecture (TS 33.501) controls — representing 7% coverage. The remaining 53 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 3GPP 5G Security Architecture (TS 33.501)?

53 FDA 21 CFR Part 11 controls have no direct equivalent in 3GPP 5G Security Architecture (TS 33.501). The highest concentration of gaps is in Electronic Signature with 16 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 3GPP 5G Security Architecture (TS 33.501)?

The domain with the highest gap count is Electronic Signature (16 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.