Deviation Impact Assessment Template

Equipment Details

Equipment: Terminal Sterilization Autoclave (LVP)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Product/Patient Impact

Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Actions (CAPA)

CAPA Details:

Re-Test/Requalification Decision

Re-Test/Requalification Decision:

QA Disposition

QA Disposition:

Submit Deviation Impact Assessment