A CAPA document (Corrective and Preventive Action) is a formal record used to identify, investigate, correct, and prevent quality issues or compliance deviations. CAPA documents are essential for demonstrating continuous improvement and regulatory compliance.
What Is a CAPA Document (Corrective and Preventive Action)?
CAPA documents are a core requirement in quality management systems across regulated industries. They provide documented evidence that problems are addressed systematically and prevented from recurring.
What Is a CAPA Document?
A CAPA document records the full lifecycle of an issue—from identification and root cause analysis to corrective actions and preventive measures. Regulators expect CAPA documentation to be complete, traceable, and auditable.
Why CAPA Documents Are Important
- Demonstrate compliance with regulatory requirements
- Ensure quality issues are properly investigated
- Prevent recurrence of nonconformances
- Support audits, inspections, and certifications
Corrective Action vs Preventive Action
- Corrective action: Addresses the root cause of an existing problem
- Preventive action: Eliminates potential causes before issues occur
Common CAPA Document Examples
- Deviation and nonconformance reports
- Audit findings and inspection observations
- Customer complaints and incident reports
- Process or quality system failures
Industries That Require CAPA Documentation
- Pharmaceuticals and biotechnology
- Medical devices and healthcare
- Manufacturing and quality-driven industries
- Regulated life sciences organisations
How CAPA Documents Support Compliance
CAPA documentation provides auditors with evidence that issues are identified, investigated, corrected, and prevented. Incomplete or ineffective CAPA records are a common cause of regulatory findings.
Manual vs Digital CAPA Management
- Manual CAPA: Spreadsheets and paper records with limited traceability
- Digital CAPA: Controlled workflows, approvals, and audit trails
Best Practices for CAPA Documentation
- Standardise CAPA templates and workflows
- Perform thorough root cause analysis
- Track effectiveness and closure
- Maintain complete audit trails
Next Steps for Organisations
- Review CAPA procedures and documentation quality.
- Identify gaps in traceability and approvals.
- Adopt a document management system that supports CAPA workflows.
Learn how modern document management platforms support CAPA documentation by exploring document management software features, book a demo, or contact our team.
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Frequently Asked Questions
What is a CAPA document used for?
A CAPA document is used to record corrective and preventive actions taken to address quality or compliance issues.
Is CAPA documentation mandatory?
Yes. Most quality and regulatory frameworks require documented CAPA processes.
What happens if CAPA documentation is weak?
Weak CAPA documentation often results in audit findings, regulatory actions, and repeat issues.
Can CAPA documents be managed digitally?
Yes. Digital systems improve traceability, approvals, and audit readiness for CAPA documentation.
