What this CAPA report covers
Report completion overview
Completion measures populated core fields only. It is not a measure of CAPA effectiveness or regulatory compliance.
Generated CAPA report
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How to use this CAPA report generator
- Assign a unique CAPA identifier and record the source, detection date, severity, and accountable owner.
- Describe the nonconformance using objective facts and identify the requirement that was not met.
- Record containment, product impact, data integrity considerations, and the extent of the affected condition.
- Document the investigation and evidence supporting the root-cause conclusion.
- Define actions that address the cause, including owners, due dates, deliverables, and completion evidence.
- Set effectiveness criteria before verification and document actual results against those criteria.
- Review the complete record under your organization's procedures and retain the approved record in the designated quality system.
Frequently asked questions
What is a CAPA report?
A CAPA report documents a quality problem or nonconformance, its investigation, the cause identified, actions taken to address the cause, and the evidence used to determine whether those actions were effective. It may also document risk, approvals, and closure rationale.
What is the difference between a correction and corrective action?
A correction addresses the detected nonconforming condition. Corrective action addresses its cause to reduce the likelihood of recurrence. Preventive action aims to address potential problems or similar risks before they occur, where appropriate to the applicable quality system.
What should a root-cause analysis include?
It should describe the investigation method, records and evidence reviewed, relevant observations, contributing factors, the cause conclusion, and the rationale connecting the evidence to that conclusion. A method such as 5 Whys or fishbone analysis can help, but the method alone does not prove the cause.
How do you verify CAPA effectiveness?
Define objective acceptance criteria, a suitable sampling or monitoring plan, the responsible reviewer, and the evidence to be examined. Compare the actual results with the criteria. If the criteria are not met, document the response according to your organization's procedure rather than assuming the CAPA is effective.
Can this tool be used for eDHR nonconformances?
Yes. It can help structure investigations involving missing or incorrect electronic device history records, traceability gaps, access-control issues, audit trail findings, record review problems, or manufacturing workflow errors. Add the relevant system, batch, record, and change-control references and follow the organization's applicable procedures.
Does generating this report make a CAPA compliant?
No. This is a drafting aid, not a compliance determination. Requirements depend on the applicable jurisdiction, product, quality system, and current regulatory framework. Your organization must review applicability, completeness, evidence, approvals, record controls, and retention requirements.
Further reading
- Electronic Code of Federal Regulations — 21 CFR Part 820
- U.S. FDA — Corrective and Preventive Actions (CAPA)
- ISO 13485:2016 — Medical devices quality management systems
These resources provide background only. Confirm the current version, applicability, and requirements for your specific organization and jurisdiction.