Cross-Framework Mapping

ISO/IEC 27006:2024vs21 CFR Part 211 - Current Good Manufacturing Practice

See exactly how ISO/IEC 27006:2024 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

13
Controls Mapped
39
Gaps Found
13%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27006:2024 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 13% coverage across 7 directly mapped controls. Analysis of 52 ISO/IEC 27006:2024 controls identifies 53 compliance gaps — primarily concentrated in Clause 6: Resource Requirements.

Source: TheArtOfService Knowledge Graph | 52 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 13 of 13 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Clause 6: Resource Requirements(11 mappings)

ISO-15189-6.3Facilities and environmental conditions3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination
ISO-15189-6.5Equipment calibration and metrological traceability3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination
ISO-15189-6.7Service agreements
CFR211-A-3Section 211.3 - Definitions
ISO-15189-6.8Externally provided products and services
CFR211-J-184Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records
ISO-17025-6.5Metrological traceability3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination

Clause 5: Structural Requirements(2 mappings)

ISO-17025-5.1Legal entity
CFR211-A-3Section 211.3 - Definitions
ISO-17025-5.4Personnel for the management system
CFR211-A-3Section 211.3 - Definitions

Related Comparisons

Other ISO/IEC 27006:2024 comparisons

Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons

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What are the key differences between ISO/IEC 27006:2024 and 21 CFR Part 211 - Current Good Manufacturing Practice?

ISO/IEC 27006:2024 has 52 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 7 overlapping controls (13% coverage). The frameworks diverge most significantly in Clause 6: Resource Requirements, where 11 ISO/IEC 27006:2024 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.

How many controls map between ISO/IEC 27006:2024 and 21 CFR Part 211 - Current Good Manufacturing Practice?

Of 52 total ISO/IEC 27006:2024 controls, 7 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 13% 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 ISO/IEC 27006:2024 to 21 CFR Part 211 - Current Good Manufacturing Practice?

53 ISO/IEC 27006:2024 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Clause 6: Resource Requirements with 11 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 ISO/IEC 27006:2024 and 21 CFR Part 211 - Current Good Manufacturing Practice?

The domain with the highest gap count is Clause 6: Resource Requirements (11 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.