Water for Injection System (WFI Generation) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment: Water for Injection System (WFI Generation)

Area: Utilities

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details:

Classification:

Major
Minor
Critical

Product/Patient Impact:

Data Integrity Impact:

Affected Batches/Studies:

Investigation:

CAPA:

Re-test/Requalification Decision:

QA Disposition:

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