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.