> ## Documentation Index
> Fetch the complete documentation index at: https://docs.elevatedsignals.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# 21 CFR Part 11 / EU Annex 11

> How Invariant controls map to predicate-rule expectations.

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          |

<Note>
  "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.
</Note>