Cross-Framework Mapping

ISO 27005vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO 27005 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

4
Controls Mapped
36
Gaps Found
12%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 27005 maps to ICH Q10 - Pharmaceutical Quality System with 12% coverage across 4 directly mapped controls. Analysis of 40 ISO 27005 controls identifies 36 compliance gaps — primarily concentrated in Risk Assessment.

Source: TheArtOfService Knowledge Graph | 40 controls analysed | 706 frameworks | 324K+ cross-framework mappings

Control Mappings

Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 324K+ mappings across 706 frameworks.

ISO 27005: Risk Framework & Governance(2 mappings)

ISO27005-01Risk management policy and scope
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ISO27005-05Risk management integration
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)

ISO 27005: Risk Monitoring & Review(2 mappings)

ISO27005-18Risk register maintenance
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ISO27005-19Continuous improvement of risk processes
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review

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What are the key differences between ISO 27005 and ICH Q10 - Pharmaceutical Quality System?

ISO 27005 has 40 controls across its framework, while ICH Q10 - Pharmaceutical Quality System covers 6 controls. Direct mapping analysis identifies 4 overlapping controls (12% coverage). The frameworks diverge most significantly in Risk Assessment, where 8 ISO 27005 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO 27005 and ICH Q10 - Pharmaceutical Quality System?

Of 40 total ISO 27005 controls, 4 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 12% coverage. The remaining 36 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 27005 to ICH Q10 - Pharmaceutical Quality System?

36 ISO 27005 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Risk Assessment with 8 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 27005 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Risk Assessment (8 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.