Explosion-Proof HVAC System – Deviation Impact Assessment

Deviation Impact Assessment

Equipment Details

Equipment: Explosion-Proof HVAC System

Area: System

Criticality: Indirect

Product Impact: Control environmental conditions safely

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Potential Impact on Product/Patient:

Data Integrity Impact

Data Integrity Impact Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

Proposed CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

See also  Desiccant Inserter (if required) – Equipment Validation SOP

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