Our client, a sizeable French laboratory operating worldwide, wants a solution to manage the move of equipment from several laboratories to a single new building.
To manage the different steps of these transfers, our client wants to replace Excel files with a complete, intuitive, and easy-to-use tool. The project started in 2019 and is expected to end in 2024.
GxpManager embarked on this project by creating a GxpXL mock-up and participating in defining the process to be implemented to manage equipment transfers.
The working group set up was made up of less than 10 people to represent the different actors of the moving process.
Identify all the steps required to move equipment, and structure an associated project management approach.
This will allow defining a simple and fluid tool by avoiding the implementation of workflows, for example. The solution must allow, through various and powerful indicators, to efficiently manage the different activities. It must facilitate the traceability of equipment with labels that include an identifier and information on the origin and destination.
The data entry forms must limit the manual entry of information to promote standardization and errors (data integrity). In addition, they are optimized to facilitate the entry of the numerous information associated with the equipment.
The application must be able to integrate information from SAP in a punctual way.
Implementation of the GxpXL application was carried out in 2 sessions and allowed the build of a mock-up of the expected application.
The project was scaled in 3 sprints over 3 months during the lockdown. During the sprints, the key users could align the vision of their needs with the possibilities of the GxpXL platform, then test and evolve the application according to the feedback.
The application allows the equipment to be grouped into batches and tracked from its start location to its end location.
The application allows the client to:
- Gain in productivity
- Optimize the monitoring of equipment and batches
- Facilitate the entry and research of information concerning a batch or equipment
- Trace all modifications/deletions/creations of information thanks to the audit trail
- Extract data in standardized and controlled formats
- Manage mandatory information entries
- Exploit the data entered to edit reports in Word or PDF and Excel format, depending on the rights
- Secure access to the application and its content in a precise manner
- Have an outline and indicators of the activity
- Have an overview of the moving activities
GxpXL is an application that complies with the requirements and recommendations applicable to electronic records, electronic signatures, and computerized systems: FDA 21 CFR part 11, GMP Annex 11, GMAP 5.
GxpManager has developed a platform that integrates powerful functionalities: traceability, security, flexibility, reporting, and analysis. It allows you to create (without coding) customized compliant applications in response to your issues and needs.
The application fits your business logic and respects your organization and your processes. Together with you, we study your needs and translate your business processes into applications. Thanks to its “super agile” generator, users are more involved in creating, evolving, and permanently enriching applications.
The applications are made available as SaaS to optimize the speed of implementation, immediate integration, flexibility, and administration of the delegated infrastructure.
The infrastructure supporting the GxpManager software and applications allows you to:
- Have a reliable and efficient platform
- An efficient disaster recovery solution to guarantee the availability of applications (necessary for the signature of new customer contracts)
The data is hosted in the Cloud, in France, in highly secure Data Centers certified ISO 27001: 2013.