Deviation Impact Assessment
Equipment Details
Equipment: Peristaltic Pump (Binder Addition)
Area: Production/Granulation
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Insert detailed description of the deviation here]
Date of Occurrence: [Insert date]
Reported By: [Insert name]
Classification
Classification of Deviation: Major
Product/Patient Impact
Impact Assessment: [Insert assessment of product/patient impact]
Data Integrity Impact
Assessment of Data Integrity Impact: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches/studies]
Investigation
Investigation Summary: [Insert summary of investigation]
Investigation Findings: [Insert findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Insert summary of CAPA]
Actions Taken: [Insert actions taken]
Responsible Person: [Insert name]
Re-test/Requalification Decision
Decision: [Insert decision regarding re-test/requalification]
Quality Assurance (QA) Disposition
QA Disposition: [Insert QA disposition]