Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsAustralia NHMRC National Statement on Ethical Conduct in Human Research

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to Australia NHMRC National Statement on Ethical Conduct in Human Research. Pre-computed mappings, identified gaps, and coverage analysis.

2
Controls Mapped
55
Gaps Found
2%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to Australia NHMRC National Statement on Ethical Conduct in Human Research with 2% coverage across 1 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 56 compliance gaps — primarily concentrated in Subpart J — Records and Reports.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart A — General Provisions(2 mappings)

CFR211-A-3Section 211.3 — Definitions2 targets
Art. 17Governance Structure
DMF-1.2Roles and Responsibilities

Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

Other Australia NHMRC National Statement on Ethical Conduct in Human Research comparisons

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and Australia NHMRC National Statement on Ethical Conduct in Human Research?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while Australia NHMRC National Statement on Ethical Conduct in Human Research covers 25 controls. Direct mapping analysis identifies 1 overlapping controls (2% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct Australia NHMRC National Statement on Ethical Conduct in Human Research equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and Australia NHMRC National Statement on Ethical Conduct in Human Research?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 1 map directly to Australia NHMRC National Statement on Ethical Conduct in Human Research controls — representing 2% coverage. The remaining 56 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 211 — Current Good Manufacturing Practice to Australia NHMRC National Statement on Ethical Conduct in Human Research?

56 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in Australia NHMRC National Statement on Ethical Conduct in Human Research. The highest concentration of gaps is in Subpart J — Records and Reports with 9 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 211 — Current Good Manufacturing Practice and Australia NHMRC National Statement on Ethical Conduct in Human Research?

The domain with the highest gap count is Subpart J — Records and Reports (9 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.