Deviation Impact Assessment
Equipment Details
Equipment: Bottle Unscrambler
Area: Packaging/Primary
Criticality: Major
Product Impact: Indirect
Deviation Details
Description of Deviation: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: Major
Product/Patient Impact
Impact Description: [Enter detailed description of product/patient impact]
Data Integrity Impact
Impact Description: [Enter detailed description of data integrity impact]
Affected Batches/Studies
Batch/Study Numbers: [Enter affected batch/study numbers]
Investigation
Investigation Summary: [Enter summary of investigation]
Findings: [Enter findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Enter summary of CAPA]
Re-test/Requalification Decision
Decision: [Enter re-test/requalification decision]
Quality Assurance (QA) Disposition
Disposition: [Enter QA disposition]