Framework overlap

Does ISO/SAE 21434 cover Annex 11 to EU GMP?

You hold ISO/SAE 21434 and have been told to do Annex 11 to EU GMP. Here is how much overlaps, control by control.

53% of Annex 11 to EU GMP you already have

ISO/SAE 21434 already covers about 53% of Annex 11 to EU GMP, leaving 8 of 17 controls as genuinely new work.

Already covered 5 Likely covered 4 New work 8

What is genuinely new work

Nothing in ISO/SAE 21434 reaches these. This is the list to scope.

Clause 11
Periodic evaluation
Clause 14
Electronic signatures
Clause 15
Batch release
Clause 17
Archiving
Clause 4
Validation
Clause 5
Data
Clause 6
Accuracy checks
Clause 8
Printouts
Show the 9 you already have
Clause 10
Change and configuration management
Clause 12
Security
Clause 2
Personnel
Clause 3
Suppliers and service providers
Clause 9
Audit trails
Clause 1
Risk management
Clause 13
Incident management
Clause 16
Business continuity
Clause 7
Data storage

How this is calculated

Already covered means a mapping runs from a control in ISO/SAE 21434 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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