Deviation Impact Assessment Template

Equipment Details

Equipment: Desiccant Inserter

Area: Packaging

Criticality: Major

Product Impact: Indirect

CSV Required: Yes

Deviation Details

Deviation Description: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Classification: [Insert classification of deviation]

Product/Patient Impact

Impact Assessment: [Insert assessment of product/patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert details of affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation]

Investigation Findings: [Insert findings]

CAPA (Corrective and Preventive Actions)

CAPA Summary: [Insert summary of CAPA]

Actions Taken: [Insert actions taken]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification]

Justification: [Insert justification for the decision]

QA Disposition

Disposition: [Insert QA disposition]

Comments: [Insert any additional comments]