Deviation Impact Assessment
Equipment Details
Equipment: Dispensing Booth
Area: Production/Dispensing
Criticality: Critical
Product Impact: Direct
CSV Required: No
Deviation Details
Deviation Description: [Enter detailed description of the deviation]
Date of Deviation: [Enter date]
Reported By: [Enter name]
Classification
Classification: [Enter classification, e.g., Major, Minor]
Product/Patient Impact
Impact Assessment: [Describe the potential impact on product quality and patient safety]
Data Integrity Impact
Data Integrity Assessment: [Describe any impact on data integrity]
Affected Batches/Studies
Affected Batches/Studies: [List affected batches or studies]
Investigation
Investigation Summary: [Summarize the investigation process and findings]
Corrective and Preventive Actions (CAPA)
CAPA Summary: [Outline the corrective and preventive actions taken]
Re-test/Requalification Decision
Decision: [State the decision regarding re-testing or requalification]
QA Disposition
QA Disposition: [Provide QA’s final disposition regarding the deviation]
Additional Comments
[Enter any additional comments or notes]