PHARMACEUTICAL MANUFACTURER BIMEDA UTILIZES ZENQMS TO SUPPORT ITS CULTURE OF CONTINUOUS IMPROVEMENT

Bimeda has served the global animal health market for more than six decades. The company embraces innovation and has an ethos of continuous improvement. As they moved into a period of rapid expansion driven by organic growth and strategic acquisitions, they understood their business technology would have to keep pace. 

Colin Baker, Senior VP of Quality, recognized that, as part of that pursuit of continuous improvement, the organization would have to upgrade to a modern, interconnected quality management system (QMS). Colin commented, “The drive to move from a paper-based QMS to an electronic QMS was to give Bimeda more control, efficiency, and oversight.”

After completing their due diligence, Bimeda decided that ZenQMS would best allow them to reach those goals.

One of the benefits of an eQMS that Colin noticed right away was the frequency with which he and his team could run trending reports for all of Bimeda’s international sites. “From a compliance standpoint, one of the things you can’t easily get from a paper system is trend analysis,” said Colin. “Where we might have only done it once a year because it was a massive undertaking, we’re now able to have reviews once a month.”

For Bimeda, trend analysis is especially critical given the aseptic environments of their manufacturing facilities. 

“We focus on environmental monitoring. An electronic system makes it easier to notice spikes in the data, and we can grab that information very quickly. We’ve set up our custom fields to where we can pull up these trends a lot easier and react faster.” 

The speed with which Bimeda can now access information has also had a positive effect on their audits by the FDA and Ireland’s Health Products Regulatory Authority. “Hosting off-site regulatory inspections with ZenQMS has been a game-changer,” said Mary Fries, Senior Document Control Specialist. “We can easily and quickly populate data, export it, and send it to them. In a GMP sense, the faster you get information to inspectors, the better, as it gives them confidence in your company’s GMP practices.”

As Bimeda has continued to grow, ZenQMS has grown with them. Because of the diversity of their global facilities, from sterile manufacturing and R&D, to distribution, diagnostics, and contract services, each site has different priorities. “We wanted to give the sites a lot of flexibility as to how and when they were implemented, so they could focus on the modules with the biggest impact,” said Colin.

Bimeda was able to accomplish this easily because ZenQMS doesn’t restrict usage by seat license or module. All modules are included right out of the box, giving customers like Bimeda the freedom to implement the ones they want and assign permissions at a granular level. And ZenQMS is highly configurable – meaning that the company can both enforce global standards or allow site specific processes for document approvals, deviation process/forms/workflows, etc.  

Of course, for a company that has rapidly expanded through acquisitions, buy-in to a new software system at these sites can be difficult. Employees have their routines and are hesitant to change the way they’ve done things, and that includes training compliance. However, what Colin and Mary have shown is that, with ZenQMS, not only can users complete their training compliance faster, they’ll also see practical benefits like reduced deviations and CAPA because information is always at their fingertips. Bimeda has even equipped its operators with internet-connected tablets so they can sign off on investigations wherever they are, instead of having to return to an office to flip through a binder. 

An additional benefit of ZenQMS is that, because everyone has access with a unique login, accountability increases. “Quality has the oversight to make sure everything gets done in a GxP-appropriate manner, but having ZenQMS moves some of the responsibility off of QA and onto individual users to own their investigations and CAPA,” said Mary. “That way, it doesn’t always fall on Quality to complete tasks and make sure everything gets done. ZenQMS has positively affected the quality culture at Bimeda, most definitely.”

“ZenQMS is an excellent quality management system that allows us to control quality and ensure compliance from anywhere,” said Colin. “In a modern work environment, and particularly for a global business, having a tool that allows for efficient collaboration is key.”

Whether you have eleven manufacturing sites or just one, ZenQMS can help you increase efficiency and stay compliant. Schedule a consultation with one of our sales reps to learn more.