Phase 1 — Foundation
Stand up the regulated spine: data, orchestration, e-signature, and the first six agents. Establish the staging gate as the architectural contract for every regulated write.
| Workstream | Status | Shipped |
|---|---|---|
Data spine (Supabase + Drizzle + RLS) cro.* schema in Supabase with RLS deny-by-default, pgvector enabled, append-only provenance_event, staging_record, and signature tables. Drizzle migrations applied to project clkifpedvomnpgajdsid. | done | 2026-02-12 PR #12 |
Orchestrator kernel services/orchestrator with the governor policy enforcement, staging-write contract, and provenance emitter. Every regulated action flows through governor.ts. | done | 2026-02-20 PR #18 |
E-signature service (21 CFR Part 11) services/esign with re-authentication, stated intent, immutable signature row, and the staging→live promotion gate. | done | 2026-03-04 PR #27 |
Audit-trail agent (27) agents/27-audit-trail surfaces ALCOA+ gaps from the provenance log and proposes remediations into staging. Agents: 27-audit-trail | done | 2026-03-18 PR #35 |
Knowledge / RAG agent (30) agents/30-knowledge-rag with pgvector-backed citation-grounded retrieval. Rejects any non-cited claim via packages/citations. Agents: 30-knowledge-rag | done | 2026-03-26 PR #41 |
Evaluation agent (31) agents/31-evaluation runs the promptfoo golden suite, gates prompt changes on model-registry version bumps, and ships eval dashboards. Agents: 31-evaluation | done | 2026-04-02 PR #46 |
Essential Documents agent (04) agents/04-essential-documents authors and tracks ICF, protocol, IB, and other TMF essentials. A2 supervised — drafts to staging, human signs. Agents: 04-essential-documents | done | 2026-04-15 PR #52 |
Web inspection view apps/web /inspection page surfaces the full evidence binder — signed records, provenance events, agent decisions, linked SOPs — in a single navigable view. | done | 2026-04-22 PR #50 |
L5 web consoles (recent features) The web app at apps/web has shipped a full suite of consoles: staging, studies, agents, costs, risks, timeline, compliance, sitemap, digest, glossary, models, tour, /me, search, and validation registry. | done | 2026-06-04 PR #81 |