Cross-Framework Mapping

ISO 27019vsICH Q10 - Pharmaceutical Quality System

See exactly how ISO 27019 controls map to ICH Q10 - Pharmaceutical Quality System. Pre-computed mappings, identified gaps, and coverage analysis.

5
Controls Mapped
41
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO 27019 maps to ICH Q10 - Pharmaceutical Quality System with 9% coverage across 4 directly mapped controls. Analysis of 46 ISO 27019 controls identifies 42 compliance gaps — primarily concentrated in Operations.

Source: TheArtOfService Knowledge Graph | 46 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 5 of 5 mapped controls across 1 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

ISO 27019: Supply Chain & Configuration(5 mappings)

ISO27019-21Supply chain risk management for critical components
ICH-Q10-Section1-Enablers-KnowledgeMgmt-QRM-FoundationICH-Q8-Q9ICH Q10 Section 1 - PQS Enablers + Knowledge Management + Quality Risk Management (ICH Q9 Foundation)
ISO27019-22Configuration management for OT systems
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ISO27019-23Change management procedures2 targets
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management
ICH-Q10-Section3-ContinualImprovement-ProcessPerformance-CAPA-ChangeMgmt-MgmtReviewICH Q10 Section 3 - Continual Improvement + Process Performance and Product Quality Monitoring + CAPA + Change Management + Management Review
ISO27019-24Vulnerability assessment for critical systems
ICH-Q10-Section2-Outsourced-Ownership-Vendor-Supplier-CMO-CROICH Q10 Section 2 - Outsourced Activities + Management of Materials + Change of Ownership + CMO + CRO + Supplier Management

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What are the key differences between ISO 27019 and ICH Q10 - Pharmaceutical Quality System?

ISO 27019 has 46 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 Operations, where 5 ISO 27019 controls have no direct ICH Q10 - Pharmaceutical Quality System equivalent.

How many controls map between ISO 27019 and ICH Q10 - Pharmaceutical Quality System?

Of 46 total ISO 27019 controls, 4 map directly to ICH Q10 - Pharmaceutical Quality System controls — representing 9% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO 27019 to ICH Q10 - Pharmaceutical Quality System?

42 ISO 27019 controls have no direct equivalent in ICH Q10 - Pharmaceutical Quality System. The highest concentration of gaps is in Operations 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 27019 and ICH Q10 - Pharmaceutical Quality System?

The domain with the highest gap count is Operations (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.