ZenQMS helps European CDMO Xpress Biologics stay cGMP compliant

A critical decision about compliance

No life sciences company would ever complain about growing their customer base. However, there is a downside. With more clients, and now more employees, the Quality team at Xpress Biologics found themselves with a similar problem faced by other CDMOs: their paper-based training management was becoming unmanageable. Once quality documents and training records are not in a state of control, regulatory compliance is compromised, and audits get stressful. Solving this pain point was the main reason why QA Officers Isabelle Renson and Didier Maury began their search for an electronic quality management system (eQMS).

“With the administrative burden that a paper-based system generates and our significant growth over the last 2 years, our quality demands expanded considerably. It was essential that we switch to an electronic system,” said Isabelle. 

Didier concurred. “It’s possible to work on paper when you’re just a few people. Now we’re at 100 and we have more customers. We’re compliant with cGMP regulations, so we need to have perfect traceability of our documentation and training records. That became very difficult and time consuming to do with a paper-based system.”

Audit-ready at all times 

The need to fulfill their own strict manufacturing standards led them to choose ZenQMS, a quality management software that is compliant with GDPR, ISO 9001 & ISO 27001 certifications, and 21 CFR Part11/Annex 11 requirements. 

Xpress Biologics was put further at ease because ZenQMS includes a full suite of modules, including those for Documents and Training, the two key areas they needed to upgrade from their paper-based QMS. When you add a host of new customers, they inevitably come with questions, so it became critical for Xpress Biologics to quickly address their concerns, especially regarding the transparency and organization of their training materials. 

“We had several customer audits where our training management was challenged. Our customers need to have evidence that our employees have received the appropriate training. With ZenQMS, it’s easy to provide this evidence and satisfy their concerns,” said Didier.

“There’s a practical path in the ZenQMS Training module for Events and OJT (on-the-job training) that facilitates putting all of our training material in the same place,” added Isabelle. “The system also features a powerful keyword search feature that enables us to find our documents in just a few clicks, which saves us a considerable amount of time.”

It’s one thing to be able to share evidence of training compliance. It’s another thing to have training compliance in the first place. With its intuitive interface and training dashboard, ZenQMS provides Xpress Biologics’ employees with immediate visibility of upcoming, completed, and past due assignments, allowing more autonomy over their own compliance. The results have led Didier and Isabelle to feel a combination of confidence and relief.

“People now know exactly what they have to do, in real time. They’re much more involved and responsible with their training,” said Didier. 

Isabelle added, “The dashboard is practical and easy to use, making the system accessible to all of our employees, whatever their function.”

A bright future ahead: The right QMS for manufacturing

The Quality team at Xpress Biologics chose to prioritize the implementation of their Documents and Training modules, but that doesn’t mean they’re done improving their quality system. During implementation and validation, (which was accelerated thanks to a robust validation package that included free UAT templates, URS checklists, and scripts), Isabelle was able to “play” in the Sandbox environment. It was there that she came to understand all the tools at her disposal, including three additional modules. 

“The way ZenQMS is structured, there’s a connection between the various modules, enabling us to later manage CAPAs, Deviations, Change Control, and other quality system tools clearly, solidly, and fluidly. The Sandbox allowed me to discover functionalities that I probably wouldn’t have thought of. Once I was in, I saw all the potential!”

If you’re looking to stay audit-ready with your training, and compliant with your regulatory guidelines, schedule a demo with ZenQMS to learn how we can bring more efficiency to your business.