Deviation Impact Assessment

Equipment Information

Equipment: Coding Machine

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Deviation Classification: [Insert classification]

Product/Patient Impact

Impact on Product: [Insert product impact]

Impact on Patient: [Insert patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment]

Affected Batches/Studies

Affected Batches/Studies: [Insert affected batches/studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Investigation Findings: [Insert findings]

CAPA

Corrective Actions: [Insert corrective actions]

Preventive Actions: [Insert preventive actions]

Re-test/Requalification Decision

Re-test Decision: [Insert decision]

Requalification Decision: [Insert decision]

QA Disposition

QA Disposition: [Insert disposition]