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Cross-Framework Mapping

ICH E6(R3) - Good Clinical PracticevsFDA Quality Management System Regulation (QMSR)

See exactly how ICH E6(R3) - Good Clinical Practice controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

12
Controls Mapped
0
Gaps Found
56%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ICH E6(R3) - Good Clinical Practice maps to FDA Quality Management System Regulation (QMSR) with 56% coverage across 5 directly mapped controls. Analysis of 9 ICH E6(R3) - Good Clinical Practice controls identifies 4 compliance gaps — primarily concentrated in ICH E6 Data Mgmt + External Data + Regulatory.

Source: TheArtOfService Knowledge Graph | 9 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 12 of 12 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

ICH E6 Annex 1 - Electronic Systems(5 mappings)

ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrityICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity5 targets
→QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→QMSR-ISO13485-Sec6Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
→QMSR-ISO13485-Sec7_DesignControlsProduct realization - Design and Development controls (ISO 13485:2016 Section 7.3)
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)
→QMSR-ISO13485-Sec8Measurement, analysis and improvement (ISO 13485:2016 Section 8)

ICH E6 Annex 2 - Decentralised Elements(2 mappings)

ICH-E6-Annex2-DecentralisedClinicalTrials-DCT-eConsent-Remote-WearablesICH E6(R3) Annex 2 - Decentralised Clinical Trial (DCT) Elements + eConsent + Remote Monitoring + Wearables + Real-World Evidence2 targets
→QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→QMSR-ISO13485-Sec7_DesignControlsProduct realization - Design and Development controls (ISO 13485:2016 Section 7.3)

ICH E6 Essential Documents(2 mappings)

ICH-E6-EssentialDocs-TMF-eTMF-ArchiveRetention-ICH-Section8ICH E6 Section 8 - Essential Documents + Trial Master File (TMF) + eTMF + Archive + Retention2 targets
→QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→QMSR-ISO13485-Sec7_DesignControlsProduct realization - Design and Development controls (ISO 13485:2016 Section 7.3)

ICH E6 Scope + Principles(1 mappings)

ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation
→QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

ICH E6 Sponsor + Quality Risk Mgmt(2 mappings)

ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight2 targets
→QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→QMSR-ISO13485-Sec8Measurement, analysis and improvement (ISO 13485:2016 Section 8)

Related Comparisons

Other ICH E6(R3) - Good Clinical Practice comparisons

ICH E6(R3) - Good Clinical Practice vs Aged Care Quality Standards (Australia)5 mappingsICH E6(R3) - Good Clinical Practice vs Florida Digital Bill of Rights (FDBR)5 mappingsICH E6(R3) - Good Clinical Practice vs TEFCA - Trusted Exchange Framework and Common Agreement4 mappingsICH E6(R3) - Good Clinical Practice vs GAMP 5 - Good Automated Manufacturing Practice4 mappingsICH E6(R3) - Good Clinical Practice vs IEC 60601-1 - Medical Electrical Equipment Safety4 mappingsICH E6(R3) - Good Clinical Practice vs COSO Internal Control - Integrated Framework (2013)3 mappingsICH E6(R3) - Good Clinical Practice vs HITECH Act3 mappingsICH E6(R3) - Good Clinical Practice vs SWIFT CSCF3 mappings

Other FDA Quality Management System Regulation (QMSR) comparisons

SWIFT CSCF vs FDA Quality Management System Regulation (QMSR)5 mappingsBRCGS Global Standard for Food Safety Issue 9 vs FDA Quality Management System Regulation (QMSR)5 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs FDA Quality Management System Regulation (QMSR)5 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs FDA Quality Management System Regulation (QMSR)5 mappings21 CFR Part 211 - Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)4 mappingsIEC 60601-1 - Medical Electrical Equipment Safety vs FDA Quality Management System Regulation (QMSR)4 mappingsGLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 vs FDA Quality Management System Regulation (QMSR)4 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs FDA Quality Management System Regulation (QMSR)4 mappings

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What are the key differences between ICH E6(R3) - Good Clinical Practice and FDA Quality Management System Regulation (QMSR)?

ICH E6(R3) - Good Clinical Practice has 9 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 5 overlapping controls (56% coverage). The frameworks diverge most significantly in ICH E6 Data Mgmt + External Data + Regulatory, where 1 ICH E6(R3) - Good Clinical Practice controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between ICH E6(R3) - Good Clinical Practice and FDA Quality Management System Regulation (QMSR)?

Of 9 total ICH E6(R3) - Good Clinical Practice controls, 5 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 56% coverage. The remaining 4 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ICH E6(R3) - Good Clinical Practice to FDA Quality Management System Regulation (QMSR)?

4 ICH E6(R3) - Good Clinical Practice controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in ICH E6 Data Mgmt + External Data + Regulatory 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 E6(R3) - Good Clinical Practice and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is ICH E6 Data Mgmt + External Data + Regulatory (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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