This control plane turns trial deviation data into one buyer-readable surface: missing source proof, retraining gaps, CAPA pressure, stale safety attachments, and the packets needed before inspection or quality trust slips.
| Lane | Owner | Focus | Status | Findings | Next action |
|---|---|---|---|---|---|
| Deviation intake and packet triage The intake desk should surface which deviations are missing proof, not just ticket counts. |
Clinical Quality | Missing packet capture and inspection-ready deviation context | RED | 4 | Repair the two at-risk packets before inspection posture hardens. |
| Source data reconciliation Source packets need owner-safe routing before they become inspection exceptions. |
Clinical Quality | Visit source confirmation and monitoring evidence | YELLOW | 6 | Close the source confirmation gap for DEV-1042. |
| Training and retraining proof Training drift stays visible before it contaminates the CAPA packet. |
Site Training | Coordinator signoff and procedural retraining evidence | YELLOW | 1 | Complete retraining reconciliation for the delayed transcription event. |
| CAPA posture CAPA packets must stay readable to both operators and inspectors. |
Regulatory Affairs | Corrective action chronology and review-safe packet handoff | RED | 1 | Finalize the chronology and route the IMM-330 CAPA packet to review. |