Deviation Impact Assessment Template

Equipment Details

Equipment: Encapsulation Coater (Wurster/Bottom Spray)

Area: R&D/Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification of Deviation: [Insert classification]

Product/Patient Impact

Impact Assessment: [Insert details on product/patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert details on data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert details of affected batches/studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Root Cause Analysis: [Insert root cause analysis]

CAPA (Corrective and Preventive Actions)

CAPA Plan: [Insert details of CAPA]

Implementation Date: [Insert date]

Re-test/Requalification Decision

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

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

QA Disposition

QA Disposition: [Insert QA disposition]

Reviewed By: [Insert name]

Date of Review: [Insert date]