Audit Readiness
For batch ZBL-2026-001 — answer auditor questions instantly versus the paper workflow.
Audit Readiness
96%
| Auditor Question | Evidence Available | What Exists Today Without Software | Time to Answer | Risk if Not Found |
|---|---|---|---|---|
| Show me all documents for batch ZBL-2026-001 | All 6 stages, 33 linked records in one click | Physical BMR in QA cabinet, BPR in packaging room, QC records in lab — 3 locations, all paper | 45–90 mins | Auditor observes disorganisation — confidence drops |
| Is the balance calibration current for the dispensing date? | Balance BAL-03 — valid till June 2026 (linked from BAL-03-CAL) | Calibration logbook in engineering room — manually cross-referenced with BMR date | 20–40 mins | If expired cal found, entire batch integrity questioned |
| Were all operators trained on the relevant SOP? | TR-HR-2026-041 — 3 operators trained on SOP-MFG-012, valid till Dec 2026 | Training records in HR files, SOPs in QA — manual cross-check across departments | 30–60 mins | Untrained operator = critical finding, potential batch rejection |
| Show me the OOS history for this product across all batches | No OOS results for ZBL-2026-001 (OOS-QC-ZBL001) | Each QC notebook checked individually — no central view | Half a day | Pattern of OOS not visible = systematic failure missed |
| What deviations were raised in the last 6 months? | DEV-2026-014 — CLOSED (linked CAPA-2026-008) | Deviation register (paper) — manually counted, no trend data | 1–2 hours | Can't demonstrate control = major audit finding |
| Is this batch's retained sample still within shelf life? | Retained sample held till Feb 2030 (RS-QC-ZBL001) | Retained sample register in QC — manually checked | 15–30 mins | Expired retained sample = finding |
| What was the yield trend for this product over last 5 batches? | Yield 99.6% for ZBL-2026-001 (YR-PKG-ZBL001) | Yield recorded in each BMR individually — no aggregated view | 2–3 hours | Cannot demonstrate process consistency = regulatory risk |
| Show me the CAPA linked to DEV-2026-014 | CAPA-2026-008 — PENDING REVIEW (one-click trace) | CAPA file in QA — if reference not written in deviation, link is lost | 30–60 mins | Broken traceability = major finding |