Deviation Impact Assessment
Equipment Details
Equipment: Manual Inspection Booth
Area: Production
Criticality: Major
Product Impact: Direct
CSV Required: No
Deviation Details
Description of Deviation: [Insert detailed description of the deviation]
Classification
Deviation Classification: Major
Product/Patient Impact
Impact on Product/Patient: [Insert assessment of impact on product and patient safety]
Data Integrity Impact
Impact on Data Integrity: [Insert assessment of data integrity impact]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Insert summary of investigation findings]
CAPA
Corrective and Preventive Actions: [Insert details of CAPA]
Re-test/Requalification Decision
Re-test/Requalification Decision: [Insert decision regarding re-test or requalification]
QA Disposition
Quality Assurance Disposition: [Insert QA disposition]