21 CFR Part 211 — Current Good Manufacturing PracticevsTISAX — Trusted Information Security Assessment Exchange
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to TISAX — Trusted Information Security Assessment Exchange. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to TISAX — Trusted Information Security Assessment Exchange 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 F — Production and Process Controls.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 7 of 7 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(1 mappings)
Subpart G — Packaging and Labeling Control(3 mappings)
Subpart J — Records and Reports(3 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other TISAX — Trusted Information Security Assessment Exchange comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and TISAX — Trusted Information Security Assessment Exchange?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while TISAX — Trusted Information Security Assessment Exchange covers 47 controls. Direct mapping analysis identifies 5 overlapping controls (9% coverage). The frameworks diverge most significantly in Subpart F — Production and Process Controls, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct TISAX — Trusted Information Security Assessment Exchange equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and TISAX — Trusted Information Security Assessment Exchange?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 5 map directly to TISAX — Trusted Information Security Assessment Exchange 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 TISAX — Trusted Information Security Assessment Exchange?
52 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in TISAX — Trusted Information Security Assessment Exchange. The highest concentration of gaps is in Subpart F — Production and Process Controls 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 TISAX — Trusted Information Security Assessment Exchange?
The domain with the highest gap count is Subpart F — Production and Process Controls (8 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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