Deviation Impact Assessment

Equipment: Purified Water Generation System (PW System)

Area: Utilities

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation ID: [Insert Deviation ID]
Date of Deviation: [Insert Date]
Description: [Insert Description of Deviation]

Classification

[Insert Classification of Deviation]

Product/Patient Impact

[Insert Details on Product/Patient Impact]

Data Integrity Impact

[Insert Details on Data Integrity Impact]

Affected Batches/Studies

[Insert Affected Batches/Studies]

Investigation

[Insert Investigation Findings]

CAPA (Corrective and Preventive Actions)

[Insert CAPA Details]

Re-test/Requalification Decision

[Insert Re-test/Requalification Decision]

QA Disposition

[Insert QA Disposition]