Framework overlap

Does GDPR cover FDA 21 CFR Part 11?

You hold GDPR and have been told to do FDA 21 CFR Part 11. Here is how much overlaps, control by control.

54% of FDA 21 CFR Part 11 you already have

GDPR already covers about 54% of FDA 21 CFR Part 11, leaving 6 of 13 controls as genuinely new work.

Already covered 0 Likely covered 7 New work 6

No control in GDPR maps directly to one in FDA 21 CFR Part 11. 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 GDPR reaches these. This is the list to scope.

Part11.100
Electronic signatures - general requirements (21 CFR §11.100)
Part11.200
Electronic signature components and controls (21 CFR §11.200)
Part11.50_70
Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70)
Part11.Definitions
Definitions (21 CFR §11.3)
Part11.Scope
Scope and implementation (21 CFR §§11.1-11.2)
Part11.Status
21 CFR Part 11 - corpus status, FDA enforcement landscape, CSA transition
Show the 7 you already have
Part11.10
Controls for closed systems (21 CFR §11.10)
Part11.30
Controls for open systems (21 CFR §11.30)
Part11.300
Controls for identification codes and passwords (21 CFR §11.300)
Part11.AccessAndAuth
Access control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
Part11.AuditTrail
Audit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
Part11.CSV
Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
Part11.RecordRetention
Record protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

How this is calculated

Already covered means a mapping runs from a control in GDPR 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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