Cross-Framework Mapping

21 CFR Part 58 — Good Laboratory Practice (GLP)vsISO/IEC 25012:2008 — Data Quality Model

See exactly how 21 CFR Part 58 — Good Laboratory Practice (GLP) controls map to ISO/IEC 25012:2008 — Data Quality Model. Pre-computed mappings, identified gaps, and coverage analysis.

5
Controls Mapped
26
Gaps Found
10%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 58 — Good Laboratory Practice (GLP) maps to ISO/IEC 25012:2008 — Data Quality Model with 10% coverage across 3 directly mapped controls. Analysis of 31 21 CFR Part 58 — Good Laboratory Practice (GLP) controls identifies 28 compliance gaps — primarily concentrated in Test Articles and Protocol (Subparts F & G).

Source: TheArtOfService Knowledge Graph | 31 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

General Provisions (Subpart A)(4 mappings)

58.1Scope2 targets
ISO-25012-5.2Defining data quality measures
ISO-25012-5.3Planning and performing data quality evaluations
58.3Definitions2 targets
ISO-25012-5.2Defining data quality measures
ISO-25012-5.3Planning and performing data quality evaluations

Facilities (Subpart C)(1 mappings)

58.49Laboratory Operation Areas
ISO-25012-4.11Traceability

Related Comparisons

Other 21 CFR Part 58 — Good Laboratory Practice (GLP) comparisons

Other ISO/IEC 25012:2008 — Data Quality Model comparisons

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What are the key differences between 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO/IEC 25012:2008 — Data Quality Model?

21 CFR Part 58 — Good Laboratory Practice (GLP) has 31 controls across its framework, while ISO/IEC 25012:2008 — Data Quality Model covers 18 controls. Direct mapping analysis identifies 3 overlapping controls (10% coverage). The frameworks diverge most significantly in Test Articles and Protocol (Subparts F & G), where 5 21 CFR Part 58 — Good Laboratory Practice (GLP) controls have no direct ISO/IEC 25012:2008 — Data Quality Model equivalent.

How many controls map between 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO/IEC 25012:2008 — Data Quality Model?

Of 31 total 21 CFR Part 58 — Good Laboratory Practice (GLP) controls, 3 map directly to ISO/IEC 25012:2008 — Data Quality Model controls — representing 10% coverage. The remaining 28 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping 21 CFR Part 58 — Good Laboratory Practice (GLP) to ISO/IEC 25012:2008 — Data Quality Model?

28 21 CFR Part 58 — Good Laboratory Practice (GLP) controls have no direct equivalent in ISO/IEC 25012:2008 — Data Quality Model. The highest concentration of gaps is in Test Articles and Protocol (Subparts F & G) 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 21 CFR Part 58 — Good Laboratory Practice (GLP) and ISO/IEC 25012:2008 — Data Quality Model?

The domain with the highest gap count is Test Articles and Protocol (Subparts F & G) (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.