TheArtOfService
Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsSSAE 18 — Attestation Standards (SOC Reporting)

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to SSAE 18 — Attestation Standards (SOC Reporting). Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
55
Gaps Found
2%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to SSAE 18 — Attestation Standards (SOC Reporting) with 2% coverage across 1 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 56 compliance gaps — primarily concentrated in Subpart J — Records and Reports.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart A — General Provisions(2 mappings)

CFR211-A-3Section 211.3 — Definitions2 targets
→SSAE18-CC7.4CC7.4 — Incident Response
→SSAE18-PI1.1PI1.1 — Processing Integrity Definition

Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

21 CFR Part 211 — Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)8 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs US OFAC Sanctions Compliance Framework7 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs CFTC System Safeguards (17 CFR 37, 38, 39, 49)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs GLI-33 — Gaming Laboratories International Event Wagering Systems5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs EIOPA Guidelines on ICT Security and Governance (2023)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs TISAX — Trusted Information Security Assessment Exchange5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs Telecommunications Sector Security Reforms (TSSR)5 mappings21 CFR Part 211 — Current Good Manufacturing Practice vs Defence Security Principles Framework (DSPF)5 mappings

Other SSAE 18 — Attestation Standards (SOC Reporting) comparisons

TISAX — Trusted Information Security Assessment Exchange vs SSAE 18 — Attestation Standards (SOC Reporting)17 mappingsNIST Privacy Framework 1.0 vs SSAE 18 — Attestation Standards (SOC Reporting)16 mappingsCSA CCM v4 vs SSAE 18 — Attestation Standards (SOC Reporting)15 mappingsNIST SP 800-82 Rev 3 — Guide to OT Security vs SSAE 18 — Attestation Standards (SOC Reporting)15 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs SSAE 18 — Attestation Standards (SOC Reporting)14 mappingsEBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07) vs SSAE 18 — Attestation Standards (SOC Reporting)14 mappingsOman National Cybersecurity Framework vs SSAE 18 — Attestation Standards (SOC Reporting)14 mappingsSOC for Cybersecurity — Cybersecurity Risk Management Examination vs SSAE 18 — Attestation Standards (SOC Reporting)14 mappings

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and SSAE 18 — Attestation Standards (SOC Reporting)?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while SSAE 18 — Attestation Standards (SOC Reporting) covers 47 controls. Direct mapping analysis identifies 1 overlapping controls (2% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct SSAE 18 — Attestation Standards (SOC Reporting) equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and SSAE 18 — Attestation Standards (SOC Reporting)?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 1 map directly to SSAE 18 — Attestation Standards (SOC Reporting) controls — representing 2% coverage. The remaining 56 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to SSAE 18 — Attestation Standards (SOC Reporting)?

56 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in SSAE 18 — Attestation Standards (SOC Reporting). The highest concentration of gaps is in Subpart J — Records and Reports 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 21 CFR Part 211 — Current Good Manufacturing Practice and SSAE 18 — Attestation Standards (SOC Reporting)?

The domain with the highest gap count is Subpart J — Records and Reports (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

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.