Cross-Framework Mapping

ISO/IEC 27400:2022vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO/IEC 27400:2022 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
26
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27400:2022 maps to ICH Q10 - Pharmaceutical Quality System with 9% coverage across 3 directly mapped controls. Analysis of 32 ISO/IEC 27400:2022 controls identifies 39 compliance gaps — primarily concentrated in Clause 6: IoT Security Controls.

Source: TheArtOfService Knowledge Graph | 32 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 6 of 6 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Clause 1-4: Introduction and Framework(6 mappings)

27011-1Scope2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
27011-3Terms and definitions2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
27400-3Terms and definitions2 targets
ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review

Related Comparisons

Other ISO/IEC 27400:2022 comparisons

Other ICH Q10 - Pharmaceutical Quality System comparisons

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What are the key differences between ISO/IEC 27400:2022 and ICH Q10 - Pharmaceutical Quality System?

ISO/IEC 27400:2022 has 32 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 3 overlapping controls (9% coverage). The frameworks diverge most significantly in Clause 6: IoT Security Controls, where 5 ISO/IEC 27400:2022 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO/IEC 27400:2022 and ICH Q10 - Pharmaceutical Quality System?

Of 32 total ISO/IEC 27400:2022 controls, 3 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 9% coverage. The remaining 39 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27400:2022 to ICH Q10 - Pharmaceutical Quality System?

39 ISO/IEC 27400:2022 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Clause 6: IoT Security Controls with 5 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 27400:2022 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Clause 6: IoT Security Controls (5 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.