BioAgilytix’s global team of highly experienced scientific and QA professionals deliver world-leading science, proven data integrity, and deep regulatory expertise to support all phases of small and large molecule studies. They provide comprehensive GxP services to innovators all over the world, including many of the top global pharmaceutical and biotech companies.
BioAgilytix is a clinical research facility with advanced laboratories in Durham, Boston, San Diego, Hamburg, Germany, and Melbourne, Australia. As the company continued to expand globally, their complicated, paper-based quality management system (QMS) made it difficult to keep documents in a state of control and processes in line with GxP regulations.
Kara Harrison is the VP of Global QA and Corporate Compliance at BioAgilytix, and knows the frustrations that come with paper-based systems. “The spreadsheets, the manual processes…everything about chasing paper takes up so much time.”
Quality Engineer Jenn Voisine concurred. “We’d have to print out controlled copies, stamp, initial, and date them, and then the QA team would have to reconcile each one in a book. It was just a pain.”
BioAgilytix was looking for a solution that would move them away from paper and into an efficient electronic quality management system (eQMS). A few of their employees were already familiar with ZenQMS and appreciated its configuration capabilities and ease-of-use; features that were a big selling point during the selection process. “When you have people who have used a system and like it, you try to stick with it,” said Robin Stolzberg, Global Quality Engineer. “We looked at a few different QMS’, but ZenQMS just really worked well.”
“Additionally, ZenQMS and Panos [Boudouvas, ZenQMS CEO] were willing to work with us to make sure we got what we wanted from the software to move forward in a compliant manner,” said Robin. BioAgilytix shared their thoughts with ZenQMS regarding the design of the Audits module, helping assure that it met their demands for CFR Part 11 compliance and suitability within GxP environments. For BioAgilytix, this point was critical, as the company’s work involves helping their own clients navigate the complex scientific and regulatory challenges inherent in bioanalytical testing.
With hundreds of employees in multiple sites around the world, moving to ZenQMS has driven big efficiencies for BioAgilytix’ training compliance. “Every other week, I train 10-20 people on the system, and I don’t get a lot of them coming back with questions”, said Jenn. “Once I train people on ZenQMS, I can get back to my job, and that’s great.”
Jenn continued, “I’m not an IT person, I’m a microbiologist. For me to be able to do all this stuff should tell you all you need to know about the user-friendliness of the system. It didn’t require me to go to ‘Zen School’ to figure it out.”
It would be difficult to imagine a company growing at the pace of BioAgilytix without the benefits of an eQMS, especially as efficiency is concerned. “I’m in the process of helping one of our sites transition to ZenQMS,” said Kara. “The way it’s structured, it allows our quality groups to be more collaborative with our operational partners. We can go straight into the system and pull metrics faster than somebody’s Excel spreadsheet. Not having a paper-based system saves us time, which saves us money.”
Robin enjoys the user-friendliness as well, “The querying within ZenQMS is a real benefit. If I want to know who has access to a particular SOP, and I don’t have the exact title, I can just query the system with the keyword search and it pops right up. It’s nice to be able to find things in the system easily.”
But perhaps the most important benefit goes back to what attracted them to ZenQMS in the first place: the ability for BioAgilytix to configure their modules around most any need and to do it easily. “I like the configurability of the Issue and Change Control modules,” said Jenn. “When our group asks me to make a number of new changes, I can do basically whatever they want. I feel great that I can say ‘Yes!’ to all of it.”
ZenQMS helped BioAgilytix stay agile, efficient, and compliant in GxP environments around the world. Schedule a free demo to learn how we can help you too.