The CAPA SOP describes the system for identifying, recording, and managing corrective and preventive actions resulting from deviations, audits, or complaints.
It ensures continuous improvement and regulatory compliance through structured problem solving and follow-up.
This SOP is professionally written, pre-filled, and 99 % ready for approval, following ICH and GxP best practices.
Includes:
•CAPA initiation and approval procedures
•Root-cause investigation and documentation
•Implementation and effectiveness verification
•Cross-reference to Deviation and Audit SOPs
•QA responsibility and management review
A strong CAPA system demonstrates that your organization not only fixes problems but prevents them — a key inspection focus.
SOP 12 CAPA (Corrective and Preventive Actions)
Consulting Support
If you prefer expert guidance, OZQA provide QA Services, such as:
- GxP compliance (GMP and GDP)
- ISO 9001 and ISO 13485 quality systems
- QMS structure and implementation
- SOP development and process documentation
- Deviation, CAPA, Change Control, and OOS processes
- Audit and inspection preparation
- Oversight of outsourced partners
Product Details & Purchase Terms
You will receive:
- Downloadable Word files (.docx)
- ~98% pre-filled templates
- Immediate access after purchase
Important:
- No refunds (digital product)
- Requires customization