Cross-Framework Mapping

ISO/IEC 27011:2024vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO/IEC 27011:2024 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
37
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27011:2024 maps to ICH Q10 - Pharmaceutical Quality System with 9% coverage across 4 directly mapped controls. Analysis of 44 ISO/IEC 27011:2024 controls identifies 46 compliance gaps — primarily concentrated in Technological.

Source: TheArtOfService Knowledge Graph | 44 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 2 domains. Sign up to explore all 332K+ 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

Clause 5: Organizational Controls for Telecommunications(1 mappings)

27011-5.6Supplier relationships and telecom supply chain
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management

Related Comparisons

Other ISO/IEC 27011:2024 comparisons

Other ICH Q10 - Pharmaceutical Quality System comparisons

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What are the key differences between ISO/IEC 27011:2024 and ICH Q10 - Pharmaceutical Quality System?

ISO/IEC 27011:2024 has 44 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 4 overlapping controls (9% coverage). The frameworks diverge most significantly in Technological, where 11 ISO/IEC 27011:2024 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO/IEC 27011:2024 and ICH Q10 - Pharmaceutical Quality System?

Of 44 total ISO/IEC 27011:2024 controls, 4 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 9% coverage. The remaining 46 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27011:2024 to ICH Q10 - Pharmaceutical Quality System?

46 ISO/IEC 27011:2024 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Technological 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 27011:2024 and ICH Q10 - Pharmaceutical Quality System?

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

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