Corrections & Removals
Field corrections and removals with a documented reportability decision and the 21 CFR 806 clock handled.
Manage field safety corrective actions — corrections, removals, and recalls — from initiation through effectiveness. Capture the health-hazard evaluation, recall classification, and the 21 CFR Part 806 reportability decision with its rationale, so a field action stays controlled and defensible.
A controlled lifecycle with electronic-signature gates at assessment approval and closure, and closure restricted to QA; segregation of duties defaults the closer to someone other than the person who approved the assessment, and where nobody else is available the reason is recorded on the record. The reportability decision is recorded on the record, and closure is gated on a documented effectiveness check. Every step is on the immutable, hash-chained audit trail.
- ✓ Health-hazard evaluation and recall classification
- ✓ Documented 21 CFR Part 806 reportability decision and rationale
- ✓ Effectiveness check gated before closure
- ✓ E-signed at assessment approval and closure, QA-only closure, on the immutable audit trail