Context
Challenge
Solution
Results
Used Application
Context
Our client is part of an international group that manufactures medical devices. They approached GxpManager to create a custom application for defining, planning, and tracking equipment and manufacturing process qualification and validation activities.
Challenge
Our client has used Excel files to manage their qualification and validation activities. These manual methods lacked traceability and were not compliant with GxP regulations. Hence, our client wanted to invest in a compliant tool that would allow traceability of each action, simplified management, and immediate data analysis.
Solution
Implementation of the custom application solution by GxpManager:
Our technical-functional consultants configured the application in close collaboration with our client. Much of the project was done directly with our client, fostering exchange and responsiveness. This dynamic client/consultant relationship, coupled with no-code/low-code configuration technology, enabled the fast development of the application in just 12 days: requirement analysis, configuration, training, implementation support, and performance qualification (PQ).
Solution Features:- Inventory of buildings, equipment, and processes
- Qualification management
- GxP-compliant validation management
- Automatic publication of the Master Validation Plan and qualification reports: The Master Validation Plan describes all qualification and validation activities tailored to the client’s needs.
- Traceability/audit trail: All actions are traced in audit trails and tracked through electronic signatures, ensuring data integrity.
Results
- Complete traceability and compliance
- Overall process optimization through data analysis: Measuring the time spent between document drafting, verification, and approval allows our client to identify where protocol implementation takes the longest time and initiate improvement actions
- Better organization through action planning
- Improved adherence to deadlines
- Reduction in human errors
- Time savings, primarily through automatic publication of the Master Validation Plan.
Used Application
Custom Application
Key features:
- Traceability (Audit Trail)
- Electronic signature
- Versioning
- Email notification
- One-click publication