Deviation Impact Assessment

Equipment: Crystallizer

Area: 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

Deviation Classification: [Insert classification, e.g., Major, Minor]

Product/Patient Impact

Impact on Product: [Insert impact description]

Impact on Patient: [Insert impact description]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment]

Affected Batches/Studies

Affected Batches/Studies: [Insert batch/study identifiers]

Investigation

Investigation Summary: [Insert summary of the investigation]

Root Cause Analysis: [Insert root cause]

Corrective and Preventive Actions (CAPA)

CAPA Details: [Insert details of corrective and preventive actions]

Re-test/Requalification Decision

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

Details of Re-test/Requalification: [Insert details]

Quality Assurance Disposition

QA Disposition: [Insert QA decision]