Pharmaceutical CAPA Management Checklist
Ensure robust corrective actions and preventative measures with our Pharmaceutical CAPA Management Checklist. Streamline investigations, approvals, and verification - minimizing risk and maximizing quality compliance.
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Deviation Identification & Reporting
Ensuring proper identification, documentation, and initial assessment of deviations.
Deviation Date
Deviation Time
Deviation Description
Deviation Severity
Deviation Category
Batch/Lot Number (if applicable)
Location of Deviation
Supporting Documentation (e.g., photos, records)
Root Cause Investigation
Comprehensive analysis to determine the underlying cause(s) of the deviation.
Detailed Description of Deviation
Potential Root Causes (Select All That Apply)
Specify 'Other' Root Cause (if selected)
Number of Times Similar Issue Occurred Previously (if applicable)
Date of Initial Observation/Event
Supporting Data/Analysis (e.g., statistical analysis, trend charts)
Attach Supporting Documents (e.g., lab reports, equipment logs)
Corrective Action Development
Defining and documenting the actions required to prevent recurrence.
Detailed Description of Corrective Action(s)
Estimated Cost of Corrective Action (USD)
Action Responsibility (Primary Owner)
Target Completion Date
Affected Departments/Functions
Action Owner Signature
Preventive Action Implementation
Establishing proactive measures to address potential issues.
Detailed Description of Preventive Action
Estimated Cost of Implementation
Planned Implementation Start Date
Planned Implementation Completion Date
Departments Responsible
Supporting Documentation (e.g., SOP Updates, Engineering Drawings)
Risk Mitigation Strategy
CAPA Effectiveness Verification
Evaluating the impact of corrective and preventive actions.
Verification Start Date
Verification End Date
Number of Deviations Reopened (Post CAPA)
Number of New Deviations Related to Root Cause (Post CAPA)
Overall Effectiveness Rating (Based on Data)
Summary of Data Analyzed & Findings
Was the original Root Cause Effectively Addressed?
Additional Comments or Observations
CAPA Documentation & Record Keeping
Maintaining complete and accurate records of the CAPA process.
CAPA Origination Date
Detailed Description of Deviation & Initial Assessment
CAPA Number/ID
Summary of Root Cause Investigation Findings
Supporting Documentation (e.g., lab reports, investigation files)
Detailed Description of Corrective & Preventive Actions
Corrective Action Completion Date
CAPA Owner Signature
CAPA Training & Communication
Ensuring staff are trained on CAPA procedures and effectively communicating updates.
Number of Employees Trained
Training Completion Date
Training Format (e.g., Online, Classroom)
Brief Summary of Training Content
Topics Covered in Training (Select all that apply)
Trainer Signature
Training Material Version
CAPA Closure & Review
Formal closure of CAPA items and periodic review of the CAPA system's effectiveness.
Date of CAPA Closure
Summary of CAPA Resolution and Effectiveness
Number of Recurrences Post-Closure (if any)
CAPA Closure Status
Signature of Reviewer
Reviewer Name
Reviewer Title
Pharmaceutical Management Solution Screen Recording
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