This SOP defines the controlled process for evaluating, approving, and implementing changes that could affect product quality, safety, or compliance.
It ensures traceability, accountability, and proper documentation of all modifications within your QMS, manufacturing, or clinical operations.
The document is pre-filled and 99 % complete, requiring minimal adaptation before approval.
It aligns with EMA, ICH, and FDA change-management principles.
Includes:
•Change initiation and assessment criteria
•Impact and risk evaluation templates
•QA review and authorization workflow
•Implementation, verification, and closure
•Integration with CAPA and training systems
A structured Change Control process demonstrates operational control and regulatory maturity during inspections.