Deviation Impact Assessment

Equipment Details

Equipment: Vision System (Label/Code Verification)

Area: Packaging/Inspection

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description: [Insert deviation description here]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification: [Insert classification here]

Product/Patient Impact

Impact Assessment: [Insert impact assessment here]

Data Integrity Impact

Data Integrity Assessment: [Insert data integrity assessment here]

Affected Batches/Studies

Batches/Studies Affected: [Insert affected batches/studies here]

Investigation

Investigation Summary: [Insert investigation summary here]

CAPA (Corrective and Preventive Action)

CAPA Plan: [Insert CAPA plan here]

Re-test/Requalification Decision

Decision: [Insert re-test/requalification decision here]

QA Disposition

Disposition: [Insert QA disposition here]