Use case

Custom application development for equipment and process qualifications/validation

The custom application’s configuration took only 12 days. It allows for the planning and tracking of equipment, as well as manufacturing process qualification and validation activities.

Context of the digitalization request

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.

Challenges

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.

The application 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).

Bespoke Application

GxpManager

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.

The benefits

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.

Results

20% time-saving on approval of packaging items
Reduced time in the validation process for promotional materials by 30 %.
Simplified international regulatory affairs collaboration using a single platform.
Training follow-up simplified for healthcare professionals.

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