SOP 2: Document Management
This SOP defines the process for creating, approving, distributing, revising, and archiving controlled documents including Standard Operating Procedures (SOPs) and log forms.
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.
This SOP ensures documentation consistency and traceability, critical for inspection readiness.
Benefits
- Save weeks of documentation work
- Ensure consistent, GxP-aligned documentation
- Maintain controlled versions and effective dates
- Create traceable documentation and revision history
- Provide a scalable foundation for additional Quality processes
- Save weeks of documentation work
Suitable companies
- Pharmaceutical companies building or expanding a QMS
- Early stage and growing regulated companies
- Virtual and highly outsourced companies
- Companies strengthening or standardising an existing Quality process
- Quality teams looking for ready to customise documentation
- Pharmaceutical companies building or expanding a QMS
What’s included
1 SOP: Document Management
1 log form: Distribution of Controlled Documents✓ Editable Word document
✓ Prewritten GxP quality processes
✓ Ready for company specific customisation
✓ Designed to integrate with related QMS processes
✓ Suitable for paper based or electronic QMS implementation
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