About AgenusAgenus Inc. is a Lexington, Massachusetts-based biotechnology company focused on immunotherapy, a field that uses the immune system to control or cure cancer.
Judy Zahora is very familiar with the complex, ‘old-school’ quality management systems available to Life Sciences companies. As the Senior Director of Global Quality Systems and Process Improvement at Agenus, she spent years wrestling with a well-known option. Because Agenus is a growing, regulated company that occupies both GMP and GCP regulatory spaces, the limitations of Agenus’ then-current QMS proved to her that it was not fit for their purpose. As Judy began to build out the infrastructure to support continuing process growth, she found that per-seat license fees, coupled with charges for additional QMS modules, became cost prohibitive. When system operational complications continued to mount, and system support became shorter in supply, she looked for an alternative.
“Our QMS worked very specifically for GMP but was not flexible enough to be fit for purpose for GCP. Those are very different regulated spaces with very different requirements. As we grow our clinical trials, I need a system with flexibility. I need to be able to build more than one type of process. And I hate counting licenses!”
Judy brought in Key Quality and Functional Stakeholders at Agenus and began an extensive review of ten electronic QMS vendors. Along with affordability and configurability, her team made a point to focus on user-friendliness, functionality, and simplicity. A frustration with their existing QMS was that it was too restrictive with permissions, very complicated to configure, and therefore, in-house system expertise was limited.
“There is no value to that level of complication. There’s no regulatory requirement for that sort of system restriction,” said Judy. “We hire incredibly brilliant people; we’re developing cutting-edge science. If someone makes a mistake in Document Control or Training, I want them to be able to fix it. I want them to be treated like the experts they are.”
Switching from their former quality management system to ZenQMS has given Judy and her team at Agenus several benefits like simplicity and transparency.
“ZenQMS allows our Global Quality Systems Team Members to go on vacation. Before, we had only one person who really knew the system. If she was out, we had to scramble. Because ZenQMS is so easy to understand, it makes my team much more efficient. Everyone on my team has at least a basic knowledge of what everyone else does. It’s not locked down with one person.”
The ease-of-use and simplicity of ZenQMS has also positively affected Agenus’ ability to maintain compliance more effectively.
“I love that in less than 30 seconds, I can see my entire company’s training status and download it onto a spreadsheet. Before, it would've been three reports, pulled from a bunch of different places, and it would’ve taken days. It shouldn’t be hard, but it was before ZenQMS.”
Judy continued, “If an inspector wants to see my SOPs during an audit, I can assign them to a training group of one, and they can look at the SOPs in ZenQMS. I’m not pushing them to box environments where I’ll lose any audit trails. In ZenQMS, I can give an inspector access to specifically-requested SOPs and training records, easily and on-demand, without opening up the entire system for their access.”
Another benefit that ZenQMS delivers is pricing that better matches Agenus’ budget and structure. There are no seat license restrictions with ZenQMS, and every client receives all modules with 24/7/365 access. For large, regulated companies with hundreds of employees across multiple sites, purchasing individual modules and seat licenses on a per-user basis gets expensive and requires complicated tracking. ZenQMS enables Judy to electronically build processes to capture/trend/track all study-level training, incident management, change management, audits, and vendor management. This gives her the ability to aggregate data across the company and provide metrics to identify process gaps and/or opportunities for improvement.
“Manufacturing needs to be able to pull up their SOPs instantly. We need to ensure study teams have been trained on the current study documents,” said Judy. “We are supporting cutting-edge technology, but we were documenting it using the equivalent of stone tablets. With ZenQMS, all the modules are included, everyone has access all the time, and we’re not counting licenses. The best part is, ZenQMS will continue to grow with us.”
The lesson for any regulated company, big or small, with a manual quality system, or an existing electronic modular quality system, is that ZenQMS is simple for the end user, simple for the system administrator to build out, and flexible to be fit for purpose for all regulated spaces. The clear, intuitive design makes it easy to identify compliance at the clinical study level, the organizational level, and the manufacturing site level. Its user-friendliness and flexibility allow management to create a structure where information can be tracked and trended to fit the needs of any regulated spaces.
If you’re struggling with an expensive, cumbersome QMS that doesn’t work the way you’d like, there is an alternative. Schedule a demo with ZenQMS and learn how we can help make your job easier.