Cross-Framework Mapping

ISO/IEC 27003:2017vs21 CFR Part 211 - Current Good Manufacturing Practice

See exactly how ISO/IEC 27003:2017 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.

7
Controls Mapped
65
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ISO/IEC 27003:2017 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 7% coverage across 5 directly mapped controls. Analysis of 72 ISO/IEC 27003:2017 controls identifies 67 compliance gaps — primarily concentrated in Support (Clause 7).

Source: TheArtOfService Knowledge Graph | 72 controls analysed | 718 frameworks | 330K+ cross-framework mappings

Control Mappings

Showing 7 of 7 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.

Operation (Clause 8)(5 mappings)

8.5Control effectiveness review3 targets
CFR211-C-48Section 211.48 - Plumbing
CFR211-F-113Section 211.113 - Control of Microbiological Contamination
CFR211-I-176Section 211.176 - Penicillin Contamination
AS9100D-8.4Control of Externally Provided Processes, Products, Services
CFR211-J-184Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records
ISO27003-8.1Operational Planning and Control
CFR211-J-184Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records

Context of the Organization (Clause 4)(2 mappings)

ISO27003-4.2Understanding Needs and Expectations of Interested Parties
CFR211-J-184Section 211.184 - Component, Drug Product Container, Closure, and Labeling Records
ISO27003-4.3Determining the Scope of the ISMS
CFR211-A-3Section 211.3 - Definitions

Related Comparisons

Other ISO/IEC 27003:2017 comparisons

Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • 718 framework browser
  • Cross-framework mappings (330K+)
  • 824 compliance assessments
  • 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • Unlimited AI Compliance Advisory
  • Unlimited full-text search
  • Framework self-assessment
  • PDF, Excel & CSV exports
Start 7-Day Free Trial →

What are the key differences between ISO/IEC 27003:2017 and 21 CFR Part 211 - Current Good Manufacturing Practice?

ISO/IEC 27003:2017 has 72 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 78 controls. Direct mapping analysis identifies 5 overlapping controls (7% coverage). The frameworks diverge most significantly in Support (Clause 7), where 9 ISO/IEC 27003:2017 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.

How many controls map between ISO/IEC 27003:2017 and 21 CFR Part 211 - Current Good Manufacturing Practice?

Of 72 total ISO/IEC 27003:2017 controls, 5 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls — representing 7% coverage. The remaining 67 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ISO/IEC 27003:2017 to 21 CFR Part 211 - Current Good Manufacturing Practice?

67 ISO/IEC 27003:2017 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Support (Clause 7) 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 ISO/IEC 27003:2017 and 21 CFR Part 211 - Current Good Manufacturing Practice?

The domain with the highest gap count is Support (Clause 7) (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.