Our client, a worldwide biotechnology drug maker, was facing paper forms multiplication.
These forms are used to collect data, or follow a quality assurance process (e.g: change control). These forms were printed, signed, distributed, and then archived.
This client, began a project to go paperless and to digitize its forms in 2018. It selected the GxpManager solution with its GxpForms application to digitize its paper forms on two pilot sites.
Digitize over 1000 paper forms without altering the content and signature processes, without burdening users, and when possible, by simplifying the process.
Today, paper forms found in regulated industries can lead to non-conformities related to data integrity issues. They are also time consuming and environmentally unfriendly.
Implemented the “GxpForms” application in collaboration with the client, so that users could create, fill out and track form with electronic signatures and with ease.
Thanks to its agile and Low Code/No Code configurator, the client and users were more involved in the creation and the enhancement of their applications.
All of this while respecting industry regulations and keeping the forms’ integrity.
The Low Code Application (LCAP) allowed the client to:
- Store / archive digitalized forms
- Manage mandatory information entries
- Control the version of the forms
- Gain in productivity thanks to mastered validation and signature path
- Electronically sign forms from the workstation (less travel)
- Trace all modifications/deletions/creations of information thanks to the audit trail
- Use the data entered in reports in Word, PDF or Excel format
- Create performance indicators for forms monitoring
GxpForms is an application that complies with various international regulatory authority: EMA, FDA, GMP, ISO.
GxpManager has developed a platform that integrates powerful features: 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. More information
The applications are made available on SaaS to optimize implementation speed, immediate integration, flexibility and administration of the delegated infrastructure.
Any update, back up, restore and archiving operations are automated.
Cloud data is hosted in France, in highly secure Data Centers certified ISO 27001: 2013.