21 CFR Part 11 / EU Annex 11

A summary of how Invariant controls map to Part 11 / Annex 11 expectations. The full, maintained matrix — with an honest Implemented / Partial / customer-responsibility status per control — is Validation Accelerator Pack artifact A3.

Expectation	Invariant control
Audit trail (who/what/when/why)	Per-org hash-chained, tamper-evident audit with reason-for-change
Electronic signatures	Signer identity, timestamp, meaning, credential re-verification, content binding
Signature/record linking	Signatures bound to content digest + linked audit entry; append-only
Access controls	Role-based access with organization scoping
Copies / exports	CSV/PDF exports via a versioned metric contract
Operational/authority checks	Maker-checker on controlled transitions; server-side completeness gates

“Built to Part 11 / Annex 11 expectations” describes designed controls and tested behavior. It is not a statement that a deployment is certified or validated — that remains program specific.

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