Deviation Impact Assessment

Equipment Details

Equipment: Centrifugal Sifter

Area: Production/Sieving

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Description: [Insert deviation description here]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Deviation Classification: Major

Potential Impact on Product: [Insert potential impact]

Potential Impact on Patient: [Insert potential impact]

Data Integrity Impact Assessment: [Insert assessment]

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

Investigation Summary: [Insert summary of investigation]

Investigation Findings: [Insert findings]

Corrective Actions: [Insert corrective actions]

Preventive Actions: [Insert preventive actions]

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

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

QA Disposition: [Insert QA disposition]