Deviation Impact Assessment Template

Equipment Information

Equipment: Lyophilizer SCADA / Control System

Area: System

Criticality: Direct

Product Impact: Control and monitor lyophilization process

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Describe Product/Patient Impact:

Data Integrity Impact

Describe Data Integrity Impact:

Affected Batches/Studies

List Affected Batches/Studies:

Investigation

Summary of Investigation:

Corrective and Preventive Actions (CAPA)

Summary of CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Approval

Approver Name:

Approval Date: