Deviation Impact Assessment

Equipment Details

Equipment: Crimping Machine (Pump Fixing)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert deviation description here]

Date of Deviation: [Insert date here]

Reported By: [Insert name here]

Classification

Classification: [Insert classification here]

Product/Patient Impact

Potential Impact: [Insert product/patient impact assessment here]

Data Integrity Impact

Data Integrity Assessment: [Insert data integrity impact assessment here]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert investigation summary here]

CAPA

Corrective Actions: [Insert corrective actions here]

Preventive Actions: [Insert preventive actions here]

Re-Test/Requalification Decision

Re-Test/Requalification Decision: [Insert decision here]

QA Disposition

QA Disposition: [Insert QA disposition here]