Framework overlap

Does Annex 11 to EU GMP cover ISO 37301:2021?

You hold Annex 11 to EU GMP and have been told to do ISO 37301:2021. Here is how much overlaps, control by control.

43% of ISO 37301:2021 you already have

Annex 11 to EU GMP already covers about 43% of ISO 37301:2021, leaving 24 of 42 controls as genuinely new work.

Already covered 0 Likely covered 18 New work 24

No control in Annex 11 to EU GMP maps directly to one in ISO 37301:2021. Everything counted as covered is covered because both map to the same third standard, which is what a crosswalk is, but it is an inference rather than a lookup.

What is genuinely new work

Nothing in Annex 11 to EU GMP reaches these. This is the list to scope.

10.1
Continual improvement
10.2
Nonconformity and corrective action
5.1.1
Governing body and top management
5.3
Roles, responsibilities and authorities
6.2
Compliance objectives and planning to achieve them
6.3
Planning of changes
7.1
Resources
7.2
Competence
7.2.2
Employment process
7.2.3
Training
7.3
Awareness
7.5
Documented information
7.5.2
Creating and updating documented information
7.5.3
Control of documented information
8.2
Establishing controls and procedures
9.1
Monitoring, measurement, analysis and evaluation
9.1.2
Sources of feedback on compliance performance
9.1.3
Development of indicators
9.1.5
Record-keeping
9.2
Internal audit
9.2.2
Internal audit programme
9.3
Management review
9.3.2
Management review inputs
9.3.3
Management review results
Show the 18 you already have
4.1
Understanding the organization and its context
4.2
Understanding the needs and expectations of interested parties
4.3
Determining the scope of the compliance management system
4.4
Compliance management system
4.5
Compliance obligations
4.6
Compliance risk assessment
5.1
Leadership and commitment
5.1.2
Compliance culture
5.1.3
Compliance governance
5.2
Compliance policy
5.3.2
Compliance function
5.3.4
Personnel
6.1
Actions to address risks and opportunities
7.4
Communication
8.1
Operational planning and control
8.3
Raising concerns
8.4
Investigation processes
9.1.4
Compliance reporting

How this is calculated

Already covered means a mapping runs from a control in Annex 11 to EU GMP to that control. Likely covered means no direct mapping exists but both frameworks map to the same control in a third standard. New work means neither. We keep those separate rather than adding them into one friendlier number, because blending them would present a two-hop inference as a verified fact.

Coverage is not symmetric. Run it the other way and you will get a different number; both are correct.

From 332,959 cross-framework control mappings across 723 frameworks, 531 of them verified against their source documents. It does not tell you that you are compliant: a mapped control means the two standards ask for the same thing, not that you have done it.

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