DEV-030022

major • escalated • equipment

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

Batches: batch-00023

Lots: lot-00023

Equipment: eq-00023

Containment and QA Triage
  • Batch quarantined pending investigation
  • Production halted on affected line

QA decision: Reject

Risk score: 100

Attachments and Audit Trail

Attachments: DEV-23-photo.jpg

  • 2025-09-11 - Deviation opened by L. Davis