Cross-Framework Mapping

TISAX — Trusted Information Security Assessment Exchangevs21 CFR Part 211 — Current Good Manufacturing Practice

See exactly how TISAX — Trusted Information Security Assessment Exchange controls map to 21 CFR Part 211 — Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
40
Gaps Found
11%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

TISAX — Trusted Information Security Assessment Exchange maps to 21 CFR Part 211 — Current Good Manufacturing Practice with 11% coverage across 5 directly mapped controls. Analysis of 47 TISAX — Trusted Information Security Assessment Exchange controls identifies 42 compliance gaps — primarily concentrated in Information Security.

Source: TheArtOfService Knowledge Graph | 47 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.

Information Security(5 mappings)

DSPF-INFO-1Information Classification3 targets
CFR211-G-122Section 211.122 — Materials Examination and Usage Criteria
CFR211-G-125Section 211.125 — Labeling Issuance
CFR211-G-130Section 211.130 — Packaging and Labeling Operations
EIOPA-GL-10ICT Operations Security
CFR211-A-3Section 211.3 — Definitions
TISAX-IS-03Third-Party Risk Management
CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records

Assessment and Exchange(1 mappings)

TISAX-AE-03Results Exchange
CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records

Information Security Management(1 mappings)

TISAX-ISM-04Supplier and Third-Party Management
CFR211-J-184Section 211.184 — Component, Drug Product Container, Closure, and Labeling Records

Related Comparisons

Other TISAX — Trusted Information Security Assessment Exchange comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

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What are the key differences between TISAX — Trusted Information Security Assessment Exchange and 21 CFR Part 211 — Current Good Manufacturing Practice?

TISAX — Trusted Information Security Assessment Exchange has 47 controls across its framework, while 21 CFR Part 211 — Current Good Manufacturing Practice covers 57 controls. Direct mapping analysis identifies 5 overlapping controls (11% coverage). The frameworks diverge most significantly in Information Security, where 30 TISAX — Trusted Information Security Assessment Exchange controls have no direct 21 CFR Part 211 — Current Good Manufacturing Practice equivalent.

How many controls map between TISAX — Trusted Information Security Assessment Exchange and 21 CFR Part 211 — Current Good Manufacturing Practice?

Of 47 total TISAX — Trusted Information Security Assessment Exchange controls, 5 map directly to 21 CFR Part 211 — Current Good Manufacturing Practice controls — representing 11% coverage. The remaining 42 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping TISAX — Trusted Information Security Assessment Exchange to 21 CFR Part 211 — Current Good Manufacturing Practice?

42 TISAX — Trusted Information Security Assessment Exchange controls have no direct equivalent in 21 CFR Part 211 — Current Good Manufacturing Practice. The highest concentration of gaps is in Information Security with 30 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 TISAX — Trusted Information Security Assessment Exchange and 21 CFR Part 211 — Current Good Manufacturing Practice?

The domain with the highest gap count is Information Security (30 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.