Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsAS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence. Pre-computed mappings, identified gaps, and coverage analysis.

21
Controls Mapped
36
Gaps Found
9%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence with 9% coverage across 5 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 52 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 20 of 21 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart A — General Provisions(1 mappings)

CFR211-A-3Section 211.3 — Definitions
9.2Network Domain Security

Subpart C — Buildings and Facilities(6 mappings)

CFR211-C-48Section 211.48 — Plumbing6 targets
4.1External Standards
4.2Building Fabric and Facilities
5.3Management of Allergens
7.1Training and Competence
8.5Production and Service Provision
8.5.2Identification and Traceability

Subpart F — Production and Process Controls(6 mappings)

CFR211-F-113Section 211.113 — Control of Microbiological Contamination6 targets
4.1External Standards
4.2Building Fabric and Facilities
5.3Management of Allergens
7.1Training and Competence
8.5Production and Service Provision
8.5.2Identification and Traceability

Subpart I — Laboratory Controls(6 mappings)

CFR211-I-176Section 211.176 — Penicillin Contamination6 targets
4.1External Standards
4.2Building Fabric and Facilities
5.3Management of Allergens
7.1Training and Competence
8.5Production and Service Provision
8.5.2Identification and Traceability

Subpart J — Records and Reports(1 mappings)

CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records
AS9100D-8.4Control of Externally Provided Processes, Products, and Services

+1 more mappings

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Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

Other AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence comparisons

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence covers 38 controls. Direct mapping analysis identifies 5 overlapping controls (9% 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 AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 5 map directly to AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence controls — representing 9% coverage. The remaining 52 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 AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

52 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence. 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 AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence?

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.