The Archiving SOP defines the procedures for secure retention, protection, and retrieval of controlled records within your QMS.
It ensures long-term data integrity for both physical and electronic documentation in compliance with GxP requirements.
This SOP is fully written and 99 % ready for approval, providing a complete record-management framework that meets the documentation needs of biotech and life-science organizations.
Includes:
•Record classification and retention timelines
•Secure storage and controlled access
•Retrieval, restoration, and destruction procedures
•Data-integrity requirements for e-records
•QA review and traceability documentation
Implementing this SOP ensures your organization can demonstrate robust control of historical data—an essential requirement for every inspection or audit.
SOP 6 Archiving
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


