Cross-Framework Mapping

ICH Q10 - Pharmaceutical Quality SystemvsISO/IEC 27003:2017

See exactly how ICH Q10 - Pharmaceutical Quality System controls map to ISO/IEC 27003:2017. Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
0
Gaps Found
67%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH Q10 - Pharmaceutical Quality System maps to ISO/IEC 27003:2017 with 67% coverage across 4 directly mapped controls. Analysis of 6 ICH Q10 - Pharmaceutical Quality System controls identifies 2 compliance gaps — primarily concentrated in ICH Q10 Product Lifecycle Stages.

Source: TheArtOfService Knowledge Graph | 6 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 4 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

ICH Q10 Section 1 - PQS Enablers(3 mappings)

ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)3 targets
AS9100D-8.1Operational Planning and Control
ISO27003-6.1Actions to Address Risks and Opportunities
ISO27003-8.3Information Security Risk Treatment

ICH Q10 Section 2 - Management Responsibility(1 mappings)

ICH-Q10-Section2-MgmtResponsibility-Leadership-QualityPolicy-Planning-ReviewICH Q10 Section 2 - Management Responsibility + Leadership + Quality Policy + Planning + Resources + Communication + Management Review
ISO27003-4.3Determining the Scope of the ISMS

ICH Q10 Section 2 - Outsourced + Ownership(3 mappings)

ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management3 targets
AS9100D-8.4Control of Externally Provided Processes, Products, Services
ISO27003-4.2Understanding Needs and Expectations of Interested Parties
ISO27003-8.1Operational Planning and Control

ICH Q10 Section 3 - Continual Improvement(4 mappings)

ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review4 targets
AS9100D-10.2Nonconformity and Corrective Action
ISO27003-10.1Continual Improvement
ISO27003-10.2Nonconformity and Corrective Action
ISO27003-4.3Determining the Scope of the ISMS

Related Comparisons

Other ICH Q10 - Pharmaceutical Quality System comparisons

Other ISO/IEC 27003:2017 comparisons

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What are the key differences between ICH Q10 - Pharmaceutical Quality System and ISO/IEC 27003:2017?

ICH Q10 - Pharmaceutical Quality System has 6 controls across its framework, while ISO/IEC 27003:2017 covers 72 controls. Direct mapping analysis identifies 4 overlapping controls (67% coverage). The frameworks diverge most significantly in ICH Q10 Product Lifecycle Stages, where 1 ICH Q10 - Pharmaceutical Quality System controls have no direct ISO/IEC 27003:2017 equivalent.

How many controls map between ICH Q10 - Pharmaceutical Quality System and ISO/IEC 27003:2017?

Of 6 total ICH Q10 - Pharmaceutical Quality System controls, 4 map directly to ISO/IEC 27003:2017 controls — representing 67% coverage. The remaining 2 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ICH Q10 - Pharmaceutical Quality System to ISO/IEC 27003:2017?

2 ICH Q10 - Pharmaceutical Quality System controls have no direct equivalent in ISO/IEC 27003:2017. The highest concentration of gaps is in ICH Q10 Product Lifecycle Stages with 1 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 ICH Q10 - Pharmaceutical Quality System and ISO/IEC 27003:2017?

The domain with the highest gap count is ICH Q10 Product Lifecycle Stages (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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