Audit-Readiness Overview
What an assessor will ask for, and whether the evidence exists today. Document availability is not compliance — this page lists evidence status only, each item with its source. Document counts are real (parsed from the actual index); operational counts come from the DEMO snapshot and are not laboratory evidence.
| Item | Status | Source | |
|---|---|---|---|
| Controlled documents in register | 100 | MASTER-DOCUMENT-INDEX (real) | OK |
| Documents approved | 0 — all V0 DRAFT, unsigned, effective date MM-DD-YYYY | Document frontmatter (verified) | GAP |
| Policies / SOPs / Forms | 37 / 24 / 39 | MASTER-DOCUMENT-INDEX | OK |
| Visual library in this bundle | 18 WI cards · 27 infographics · 29 flowcharts | Bundled asset folders (counted live) | OK |
| Referenced forms with no file | 8 | Gap analysis 2026-10-20 §4.3 (verified) | GAP |
| Internal audits held | 0 — policy complete (LAB-QM-012), no audit held yet; no checklist instrument exists | Gap analysis 4.5.5/4.5.6 | GAP |
| Management reviews held | 0 — LAB-QM-013 requires ≥ 1/year; first review not yet held | Gap analysis 1.7.1 | GAP |
| TAT logging | PAUSED since 2026-08-22 — QI-POST-01/02 produce no records | LAB-QM-POST-003 internal note | GAP |
| Pathologist weekly visit log | MISSING — AO 2021-0037 Annex A II.A.4 requires weekly visits; no policy text, no log form | Gap analysis critical #2 | GAP |
| Critical-value timing in masters | CONFLICT: 30 min (QM-003) vs 15 min (register) — uniform 15 min DECIDED 2026-10-21, amendment pending | LAB-QM-003 §5.3.3; F-QM-003-A-V0; POST-002 §5.1 | ATTENTION |
| SPH referral MOA | NOT executed; SPH LTO copy not on file | LAB-QM-PRE-002 §5.2 (self-stated) | ATTENTION |
| NC/CAPA data in LUIB | NONE — no module exists (verified); registers are paper/forms | LUIB code inspection | ATTENTION |
| LUIB audit trail | Present by design: insert-only audit_log; snapshot shows demo events only | LUIB schema.sql / db.py | OK |