Applies ALCOA+ pharmaceutical compliance principles when creating audit trails, session ledger entries, documentation, or any records requiring regulatory compliance. Use for 21 CFR Part 11 adherence, GxP documentation, validation protocols, and audit-ready artifacts. Ensures data integrity through Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available principles.
When creating pharmaceutical documentation or audit records, ensure compliance with these 9 principles:
2026-01-14T10:30:00Z)Our .ai/session-ledger.md is ALCOA+ compliant by design:
| Principle | How Session Ledger Satisfies It |
|---|---|
| Attributable | Logs agent name + user email (from rbac-factbook.yaml) |
| Legible | Markdown, human-readable |
| Contemporaneous | System timestamps via git hooks (not LLM-generated) |
| Original | Append-only (never edited) |
| Accurate | Review Council + E2E verification ensures accuracy |
| Complete | All fields populated (agent, phase, story, decision, files, cost) |
| Consistent | Standard format enforced by protocol |
| Enduring | Git-committed, persists forever |
| Available | In-repo, searchable via grep |
When creating audit records:
$(date -u +"%Y-%m-%dT%H:%M:%SZ")