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06Governance

Every action attributed. Every approval on record. Permanently.

Every paragraph, decision, traceability link, and compliance assessment carries its own tamper-evident version history — what it was, when it changed, and whether it was AI or human. Permanently.

Every change attributed. Every AI action visible.

When the AI re-assesses a compliance item or updates a paragraph, the change is always clearly surfaced — nothing updates silently. Any item with AI provenance is flagged. A document that surfaces unreviewed AI content can be blocked from release.

/settings?moment=provenance-review
SRS-002 §4.1 — Version history
v1a3f9b2c
v28cf1a34
v3f4a8e92

Item-level version history

Every paragraph, assessment, decision, and traceability item has its own tamper-evident record.

RISK-012 §6 — Assessment
Benefit-risk conclusion

Every AI action flagged and attributable

Every AI-generated item is flagged. Unreviewed AI content structurally blocks document release.

Mandate change detected
AI re-assessing RISK-012 §6
→ Surfaced for your review

Nothing changes silently

Every AI reaction to a change surfaces immediately for your review.

SRS-002 v3
Document

Tamper-evident by design

Any alteration after signing breaks the record — permanently.

Two reviews. Always in that order.

Subject matter experts review and approve individual atoms — paragraphs, assessments, links, decisions — first. Then a separate person reviews the complete document and releases it. Both required. Neither substitutes for the other.

/documents?moment=doc-approval
SME atom-level review
§4.1 Scope
·
RISK-012 §6
·
DI-03 link
·
PROC-008 §3
·

Atom-level sign-off first

SMEs approve each paragraph, assessment, and decision individually before anything moves.

All atoms approved
Document review
Released

Document-level release second

A separate approver reviews the whole before release.

RISK-012 v2
Document
Release

Structurally enforced

Not a process guideline. The system won't release without both sign-offs.

SRS-002 — Document release
Pending signature

21 CFR Part 11 and Annex 11

Every signature legally equivalent to a wet signature under FDA and EU MDR.

See governance in action.

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