Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsWCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021). Pre-computed mappings, identified gaps, and coverage analysis.

6
Controls Mapped
51
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021) with 7% coverage across 4 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 53 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 6 of 6 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart C — Buildings and Facilities(1 mappings)

CFR211-C-48Section 211.48 — Plumbing
CTPAT-SCS-03Conveyance and Cargo Security

Subpart F — Production and Process Controls(1 mappings)

CFR211-F-113Section 211.113 — Control of Microbiological Contamination
CTPAT-SCS-03Conveyance and Cargo Security

Subpart I — Laboratory Controls(1 mappings)

CFR211-I-176Section 211.176 — Penicillin Contamination
CTPAT-SCS-03Conveyance and Cargo Security

Subpart J — Records and Reports(3 mappings)

CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records3 targets
AEO-SC-4Trading Partner Security
NRF-4Supply Chain Risk Identification
NRF-5Third-Party Partner Standards

Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

Other WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021) comparisons

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021) covers 28 controls. Direct mapping analysis identifies 4 overlapping controls (7% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021) equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 4 map directly to WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021) controls — representing 7% coverage. The remaining 53 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 WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)?

53 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021). The highest concentration of gaps is in Subpart J — Records and Reports with 8 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 WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)?

The domain with the highest gap count is Subpart J — Records and Reports (8 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.