Cross-Framework Mapping

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration LaboratoriesvsICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems

See exactly how ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls map to ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
50
Gaps Found
12%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories maps to ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems with 12% coverage across 8 directly mapped controls. Analysis of 65 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls identifies 57 compliance gaps — primarily concentrated in Clause 7: Process Requirements.

Source: TheArtOfService Knowledge Graph | 65 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Clause 6: Resource Requirements(1 mappings)

ISO-15189-6.7Service agreements
E6R2-1.1Glossary and Definitions

Clause 7: Process Requirements(3 mappings)

ISO-15189-7.4Post-examination processes3 targets
E6R2-8.1Before Clinical Phase Commences
E6R2-8.2During Clinical Conduct
E6R2-8.3After Completion or Termination

Clause 8: Management System Requirements(9 mappings)

ISO-15189-8.1General requirements2 targets
E6R2-2.13Quality Management Systems
E6R2-5.0Quality Management
ISO-15189-8.4Control of records3 targets
E6R2-8.1Before Clinical Phase Commences
E6R2-8.2During Clinical Conduct
E6R2-8.3After Completion or Termination
ISO-17025-8.1Options2 targets
E6R2-2.13Quality Management Systems
E6R2-5.0Quality Management
ISO-17025-8.7Corrective actions2 targets
E6R2-2.13Quality Management Systems
E6R2-5.0Quality Management

Clause 5: Structural Requirements(2 mappings)

ISO-17025-5.1Legal entity
E6R2-1.1Glossary and Definitions
ISO-17025-5.4Personnel for the management system
E6R2-1.1Glossary and Definitions

Related Comparisons

Other ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories comparisons

Other ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems comparisons

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What are the key differences between ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories and ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?

ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories has 65 controls across its framework, while ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems covers 22 controls. Direct mapping analysis identifies 8 overlapping controls (12% coverage). The frameworks diverge most significantly in Clause 7: Process Requirements, where 18 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls have no direct ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems equivalent.

How many controls map between ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories and ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?

Of 65 total ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls, 8 map directly to ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems controls — representing 12% coverage. The remaining 57 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories to ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?

57 ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories controls have no direct equivalent in ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems. The highest concentration of gaps is in Clause 7: Process Requirements with 18 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 17025:2017 — General Requirements for Testing and Calibration Laboratories and ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?

The domain with the highest gap count is Clause 7: Process Requirements (18 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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