Our client, a large French laboratory operating worldwide, uses Excel files to process his critical data.
This allows them to carry out the inventory of their computerized systems, the management of their suppliers, of their owners, and the associated Quality actors. This inventory management allows a periodic and global review. These Excel files are stored on a Windows server with restricted access to 50 people.
The use of Excel files for critical activities is a risk (absence of audit trail, user management…) which can lead to observations during inspections (audit) for failure to respect data integrity.
This is why this customer looked to digitize its process at the end of 2019.
Create a regulatory-compliant application that facilitates the management of the inventory process and secures the data of the R&D department.
This department needs computerized systems according to their qualification and validation status. This would allow them to track changes in information or status, and also to have these changes approved by the system owner.
The provision of activity and analysis reports is also part of the challenge. Documents in PDF format of the qualified and validated status of equipment and systems with different levels of analysis: by owners, by type of system, and at the global R&D level.
Implementation of the GxpXL application with the realization of a first scoping, followed by the writing by the customer of a user specification that GxpManager analyzed and accepted.
The Excel files were replaced by a GxpManager “Inventory” application.
The application allows the inventory of systems and equipment, the management of suppliers, system owners, and all associated Quality actors. The management of this inventory allows for a periodic and global review.
The project was sized in 3 sprints carried out over 3 months during the lockdown.
During the sprints, key users were able to align their vision of their needs with the capabilities of the GxpXL platform, and then test and update the application according to user feedback and testing.
GxpManager provided the GxpXL Platform Qualification (IQ/QO) report. The client was able to rely on the tests already performed by GxpManager to reduce its validation effort.
The GxpXL application allows:
- Respect for data integrity
- Tracking of workflows with electronic signatures in compliance with Annex 11 of GMP and 21 CFR Part 11
- Increase productivity with controlled validation and signature circuits
- Trace all modifications/deletions/creations of information thanks to the audit trail
- The use of the audit trail for periodic reviews
- The ability to extract data in standardized and controlled formats for an audit or inspection
- To manage mandatory data entry
- Use the data entered in reports in Word or PDF format, depending on rights
- Secure access to the application and its content in a precise manner
- Perform reviews of user access and rights
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: 21 CFR Part 11 compliance, 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 the creation, evolution, and permanent improvement of 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.