DEV-030020
critical • pending-closure • system
About this view
Deviation detail consolidates event narrative, impact scope, and containment progress into a single GMP-quality case view. QA triage decisions and risk assessment are tracked alongside impacted batches, lots, and equipment so release impact can be evaluated quickly. Attachments and immutable audit trail entries provide evidence continuity for inspections. Next actions focus on investigation linkage, due-date control, and closure readiness.
Event Narrative
Deviation identified during manufacturing. Investigation initiated per SOP-QA-012.
Impacted Scope
Containment and QA Triage
- Batch quarantined pending investigation
QA decision: Rework
Risk score: 17
Attachments and Audit Trail
Attachments:
- 2025-07-14 - Deviation opened by A. Williams