Deviation Impact Assessment Template

Equipment Details

Equipment: Depot Suspension Preparation Vessel

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification Level: [Insert classification level]

Justification for Classification: [Insert justification]

Product/Patient Impact

Impact on Product: [Describe the impact on the product]

Impact on Patient: [Describe the impact on the patient]

Data Integrity Impact

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

Affected Batches/Studies

Affected Batches: [List affected batches]

Affected Studies: [List affected studies]

Investigation

Investigation Details: [Outline investigation steps taken]

Findings: [Summarize findings]

CAPA (Corrective and Preventive Action)

CAPA Plan: [Detail the CAPA plan]

Responsible Person: [Insert name]

Target Completion Date: [Insert date]

Re-test/Requalification Decision

Re-test Required: [Yes/No]

Requalification Required: [Yes/No]

Details: [Insert details of re-test/requalification]

QA Disposition

QA Disposition: [Insert QA disposition]

Disposition Date: [Insert date]