CAPA Policy, SOP & Forms – FDA QMSR Compliant Template Set (MD-QMS-03)

¥317,500

CAPA Policy, SOP & Forms – FDA QMSR Compliant Template Set (MD-QMS-03)

CAPA Policy, SOP & Forms – FDA QMSR Compliant Template Set (MD-QMS-03)

¥317,500

CAPA policy, SOP, and forms for FDA QMSR-compliant corrective and preventive action management. Editable Word templates ready for QMS customization.

Preview before you buy: Download a watermarked sample PDF showing the cover, table of contents, and sample sections.

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This editable Microsoft Word template set is fully aligned to FDA QMSR (21 CFR Part 820) and ISO 13485:2016. It includes the policy, SOP, and supporting forms drawn from over 30 years of FDA inspection experience. Customizable, ready to deploy in days.


What’s Included


Policy

  • 📄 MD-QMS-K17_CAPA_Policy.docx

Procedure (SOP)

  • 📄 MD-QMS-S1701_CAPA_SOP.docx

Forms

  • 📄 MD-QMS-F1701_CAPA_Form.docx
  • 📊 MD-QMS-F1702_CAPA_Log.xlsx
  • 📄 MD-QMS-F1703_CAT_Meeting_Minutes.docx

Table of Contents (Policy Document)

  • Table of Contents
  • 1. Purpose
  • 2. Scope
  • 3. Definitions
  • 4. CAPA Management Principles
  • 5. CAPA Management Responsibility
  • 6. CAPA Information Sources
  • 7. CAPA Escalation Criteria
  • 8. CAPA Severity Classification
  • 9. CAPA Identification Number
  • 10. CAPA Progress Management
    • 10.1 CAPA Log
    • 10.2 Corrective Action Team (CAT)
  • 11. Procedure Overview
  • 12. References
  • 13. Supplementary Provisions

Aligned to 21 CFR Part 820 (QMSR) and ISO 13485:2016. Drafted by specialists with 30+ years of FDA inspection experience.



📄 Preview the Document Before You Buy

Confident purchase decisions start with knowing what’s inside. Download a watermarked sample showing the cover page, table of contents, and the first sections — so you can verify scope, structure, and language fit your QMS before adding to cart.

Table of Contents — CAPA Policy, SOP & Forms – FDA QMSR Compliant Template Set (MD-QMS-03)

  1. Purpose
  2. Scope
  3. Definitions
  4. CAPA Management Principles
  5. CAPA Management Responsibility
  6. CAPA Information Sources
  7. CAPA Escalation Criteria
  8. CAPA Severity Classification
  9. CAPA Identification Number
  10. CAPA Progress Management
  11. Procedure Overview
  12. References
  13. Supplementary Provisions

4-page sample preview
Cover · TOC · Sample sections
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The sample is provided for evaluation only. Full editable Microsoft Word files (without watermark) are delivered immediately upon purchase. © eCompliance Ltd. — All rights reserved.

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