This SOP defines the process for creating, approving, distributing, revising, and archiving controlled Standard Operating Procedures (SOPs).
It establishes a uniform and compliant system for documentation management within your Quality Management System (QMS).
The template is fully written and pre-filled (95–99% complete) and includes regulatory-compliant structure and language aligned with GxP, EMA, and FDA guidelines.
Includes:
SOP creation and approval process
Version control and numbering system
Document lifecycle management
Roles and responsibilities for QA and document owners
Controlled distribution and archiving requirements
This SOP ensures documentation consistency and traceability — critical for inspection readiness.
SOP 2 System for SOPs
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