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MINOVIA IMPLEMENTS ZENQMS AND IMMEDIATELY GAINS EFFICIENCY, TRANSPARENCY, AND CONFIGURABILITY
About Minovia Therapeutics
Minovia Therapeutics (Minovia) is a clinical stage company and the first to use a mitochondrial cell therapy approach to treat patients affected with mitochondrial diseases through its Mitochondrial Augmentation Technology (MAT) platform. Harnessing the power of mitochondria, Minovia is committed to exploring the full potential of its proprietary platform to address mitochondrial diseases ranging from orphan indications to more common and age-related diseases.
Success Highlights
Business Need
Life Sciences companies no longer need to stay tied to paper-based quality systems. There are multiple electronic quality management systems (eQMS) on the market that can ensure an operational and GXP-compliant quality management system and greatly reduce or eliminate common issues such as incomplete training, lost documents, delayed approval of quality events, signature-chasing, and “information silos”. At companies with distributed, multi-site, or virtual work environments, addressing these challenges is even more critical.
Amnon Eylath should know, as he’s implemented a variety of different systems at a number of Life Sciences companies as an organizational leader and as an experienced GXP consultant. Early-on during his time at Minovia, he made a strong case for them to adopt an eQMS and move away from their paper-only QMS. "An eQMS, even for a small company, is worth the cost because it can save an estimated one and a half to two FTE equivalents from running around trying to get signatures, searching for misplaced GXP documents, following up with staff to complete training, and close Deviations, Change Controls, CAPA management, etc.” he said. “Minovia developed a complex GMP Quality Management System with different iterations, authored by different people over the years. They also had many training records for employees that became cumbersome to manage manually using paper documents, SharePoint, and Excel.”
“An eQMS, even for a small company, is worth the cost because it can save an estimated one and a half to two FTE equivalents."
- Amnon Eylath, GxP Consultant
With so many documents and records to keep track of, Minovia was a perfect candidate to move away from their paper-based quality system. The question then became: which eQMS should they choose?
“What I’ve found is that, for companies coming off of paper or stop-gap measures like SharePoint, the layout of ZenQMS is closer to what they’re used to,” said Amnon. “We assessed a few systems, and the quality team at Minovia (notably, Rinat Marco and Jeni Tkachenko on the eQMS implementation team) preferred ZenQMS. Its tabular format was similar to what they’d been putting into their Excel spreadsheets and Smartsheets, which made it more intuitive and palatable.”
Business Impact
It’s understandable that employees who have been using the same quality management system for years would be hesitant to change. However, Amnon noted that, once Minovia’s documents were transferred and went live in ZenQMS, any thoughts about going back to paper were quickly forgotten.
“Everybody’s happy about moving away from paper,” he said. “The implementation of Document Control with Read and Understand training was not difficult, and we got up and running quickly. ZenQMS reduced much of the busywork and annoyance of people getting hounded and chased to sign documents and complete training, because you can immediately find the controlled documents and see their training status. There’s no nostalgia for the old system.” Minovia is now implementing further modules in ZenQMS, such as the Training Curriculum, Deviations/CAPA, and Change Control.
'The first thing I liked about ZenQMS was seeing the dashboard right up front.”
- Amnon Eylath, GxP Consultant
Along with enjoying the familiarity that comes from a configurable eQMS, Amnon and the team at Minovia have utilized features that aren’t as common in other solutions. “I’ve never worked with another eQMS that presented its training curriculum in such a transparent manner as ZenQMS," said Ammon. "It has the combined capabilities of quickly being able to create training courses, assigning documents to those courses, scheduling courses (including in-system approvable ‘on-the-job’ training events) as part of a curriculum, and assigning them to people who must take that course.”
That’s not to mention the clarity that comes from having an intuitive training status interface front and center, as soon as you log in.
“I’ve seen more sophisticated systems that didn’t have much of a dashboard. The first thing I liked about ZenQMS was seeing the dashboard right up front. The problem of things being ‘out of sight, out of mind’ is avoided.”
Amnon has also worked with companies that have implemented more expensive systems than ZenQMS, but those have their own set of limitations as well, beyond the significantly higher cost of implementation and licensing. “If you don’t have anyone in your company who has managed an eQMS before, those complex systems can be difficult, whereas ZenQMS is easy to manage. It has flexibility that you may not have in other systems where you’re locked into their process. And even if those systems are lowering their prices, they’re still based on how many seat licenses you need, so they may not be less expensive after all. ZenQMS doesn’t have those restrictions. The pricing structure is much better for a smaller company.” Big or small, one site or many, your regulated company deserves to move off of paper and into a more organized, efficient eQMS.
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