Deviation Impact Assessment

Equipment: Lyophilizer Stoppering System

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description: [Insert detailed description of the deviation here.]
Date of Deviation: [Insert date here.]
Reported By: [Insert name here.]

Classification

Type: [Insert classification type, e.g., Major, Minor, etc.]
Severity: [Insert severity level, e.g., High, Medium, Low.]

Product/Patient Impact

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

Data Integrity Impact

Assessment: [Insert assessment of data integrity impact here.]

Affected Batches/Studies

Batches/Studies Affected: [Insert list of affected batches/studies here.]

Investigation

Investigation Summary: [Insert summary of the investigation conducted here.]

Corrective and Preventive Actions (CAPA)

Actions Taken: [Insert details of CAPA here.]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification here.]
Rationale: [Insert rationale for the decision here.]

QA Disposition

Disposition: [Insert QA disposition here.]
Reviewed By: [Insert name of reviewer here.]
Date of Review: [Insert date here.]