Deviation Impact Assessment for WFI Storage Tank Qualification Activities

Deviation Details

Equipment: WFI Storage Tank

Area: Utilities

Criticality: Critical

Product Impact: Direct

CSV Required: No

Classification

[Insert classification of the deviation]

Product/Patient Impact

[Describe the potential impact on product quality and patient safety]

Data Integrity Impact

[Assess the impact on data integrity]

Affected Batches/Studies

[List affected batches or studies related to the deviation]

Investigation

[Summarize the investigation process and findings]

Corrective and Preventive Actions (CAPA)

[Detail the CAPA plan to address the deviation]

Re-test/Requalification Decision

[Outline the decision regarding re-testing or requalification]

Quality Assurance (QA) Disposition

[Provide the QA disposition on the deviation]