Deviation Impact Assessment

Equipment Information

Equipment: Inline Sifter (Transfer Line)

Area: Production/Sieving

Criticality: Major

Product Impact: Direct

CSV Required: No

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

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

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

Data Integrity Impact

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

Affected Batches/Studies

Affected Batches: [Insert affected batch numbers]

Affected Studies: [Insert affected study numbers]

Investigation

Investigation Summary: [Insert summary of the investigation conducted]

Findings: [Insert key findings]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Insert summary of corrective and preventive actions taken]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-testing or re-qualification]

QA Disposition

Disposition: [Insert QA disposition]