Deviation Impact Assessment

Equipment Details

Equipment: Cartridge Filling Machine

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

Deviation Classification: [Insert classification here]

Product/Patient Impact

Potential Impact on Product: [Insert impact details here]

Potential Impact on Patient: [Insert impact details here]

Data Integrity Impact

Impact on Data Integrity: [Insert data integrity impact details here]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert investigation summary here]

Investigation Findings: [Insert findings here]

Corrective and Preventive Action (CAPA)

CAPA Description: [Insert CAPA description here]

Responsible Person: [Insert name here]

Target Completion Date: [Insert date here]

Re-Test/Requalification Decision

Re-Test/Requalification Required: [Yes/No]

Details: [Insert details here]

Quality Assurance (QA) Disposition

QA Disposition: [Insert disposition here]

Disposition Justification: [Insert justification here]