Does NIST Cybersecurity Framework 2.0 cover FDA 21 CFR Part 11?

54% of FDA 21 CFR Part 11 you already have

NIST Cybersecurity Framework 2.0 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 NIST Cybersecurity Framework 2.0 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 NIST Cybersecurity Framework 2.0 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 NIST Cybersecurity Framework 2.0 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.

Try another pair · Today's edition