DEV-030383
major • closed • personnel
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
- Production halted on affected line
- Affected lots placed on hold
QA decision: Conditional release
Risk score: 100
Attachments and Audit Trail
Attachments: DEV-384-photo.jpg
- 2026-09-13 - Deviation opened by P. Martinez