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Minovia Therapeutics: Maintaining Quality Through Clinical Phases With a Scalable eQMS
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
From Paper to Digital: How Minovia Scaled QMS Document Control Over Time
When Minovia Therapeutics first set out to modernize its quality management system (QMS), the goal was simple: ditch the paperwork and gain better control over critical processes. Like many growing biotech companies, they had been managing controlled documents, training records, and compliance tracking through a paper-based QMS. This worked for a while, but quickly became a bottleneck as the company scaled.
Document control, in particular, was a huge headache. Files were scattered, approvals were slow, and keeping up with version control was a manual process that took far too much time. Relying on paper wasn’t sustainable as a GxP-regulated company, especially as regulatory requirements became more complex.
Fast forward to today, and Minovia’s quality processes have come a long way. Their move to ZenQMS brought immediate efficiency gains, but the real story is how they’ve continued to evolve their processes over time. Now, in 2025, Minovia is further along in its clinical journey, and QMS document control has never been more critical.
Here’s how ZenQMS helped Minovia transition from paper-based processes to a scalable, efficient, and compliant electronic quality management system (eQMS).
From a Paper-Based QMS to a Smooth eQMS Implementation
In 2023, Minovia brought in an experienced GxP consultant, Amnon Eylath, to help modernize its quality management processes. With prior experience implementing a range of QMS platforms across life sciences companies, the consultant recommended moving to an eQMS.
“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 chasing signatures, searching for misplaced GxP documents, and manually tracking training time.” – Amnon Eylath, GxP Consultant
At the time, Minovia’s quality processes were heavily reliant on paper, SharePoint, and Excel. Document tracking, training records, and version control were cumbersome. The goal was clear: reduce inefficiencies, increase transparency, and lay the groundwork for a system that could scale with the company’s clinical progress.
After evaluating several eQMS platforms, ZenQMS stood out above the rest. Its tabular format felt familiar, closely mirroring how Minovia had been managing documents in spreadsheets, making adoption seamless.
Within months, Minovia had fully transitioned to ZenQMS, rolling out key modules like document control and training management to replace manual processes and improve visibility across the organization.
“Everyone was happy to move away from paper. Once the system was live, any nostalgia for the old way of doing things disappeared.”
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The Immediate Benefits of an eQMS for Biotech
Once everything was live in ZenQMS, the team immediately began to see the impact:
- No more misplaced or outdated documents. Granular document control features ensured everyone was always working with the latest version.
- Automated training compliance. Employees received automatic training reminders and had a dashboard for clear visibility into training status, increasing compliance without increasing the Quality team’s workload.
- Faster approvals and workflows. No more tracking down signatures and managing status updates. Controlled workflows and automatic notifications kept Quality processes moving without micromanagement.
The transition to ZenQMS for QMS document control not only improved compliance but also eliminated inefficiencies of paper-based processes, allowing the team to focus on continuous improvement instead of administrative tasks.
A QMS Software that Scales Through Clinical Development
Now, in 2025, Minovia is further along in its clinical development journey, moving into phase 2 and preparing for phase 3. And with more SOPs, compliance requirements, and document changes to track, their reliance on strong QMS document control continues to grow.
Refining QMS Document Control & Version Management
With more methods, SOPs, and compliance expectations, document management has become a critical component of Minovia’s quality processes. The team points to ZenQMS’s flexibility as a key reason why their processes continue to improve:
“When we do a version update, like a change control, if it’s a small update, we can use the comment section to document it. With paper, you always had to document it manually. Now, it’s a much easier process that doesn’t disrupt our work.” Maayan Portnoy, Director of Quality and Analytical Development
Instead of needing additional paperwork for every single update, Minovia can now track minor changes all within ZenQMS – saving significant time without sacrificing compliance.
Measuring Success: Compliance, Efficiency, & Ownership
For Minovia, a successful eQMS isn’t just about compliance, it’s about the proper controls and ownership. The quality team has worked to ensure departments take responsibility for their own procedures, rather than relying entirely on QA to enforce them.
“The success of our work is when departments control their procedures. QA should oversee processes, not own them. The real goal is education – showing teams how compliance and procedures work so that quality is integrated into daily operations.”
ZenQMS supports this approach by making procedures more accessible and easier to manage. With a centralized, intuitive QMS software that everyone can quickly learn how to use, departments can open procedures, see what is assigned to them, and stay on top of their responsibilities. This helps shift ownership to the subject matter experts who are closest to the work, while QA remains focused on oversight and guidance.
Eliminating Redundant Processes & Saving Time
One of the biggest wins for the team was the elimination of an unnecessary change control form within their old process.
“We used to have an additional form that created unnecessary work for the QA team. When we obsoleted it, we had a huge celebration because we knew how much time it would save.”
Now, instead of requiring extra paperwork, users can upload documents directly into ZenQMS, and minor change controls can happen with a simple version update all within the same system.
Additionally, training compliance has continued to improve:
- Employees are more engaged in completing their training on time.
- The ZenQMS dashboard provides real-time visibility into training status.
- Compliance is no longer reliant on manual follow-ups.
“Everyone wants to see the green circle on their training dashboard.”
This real-time visibility and automation have significantly improved compliance rates and reduced administrative workload for the QA team – a win-win in our book!
Looking Ahead: Preparing for Future Regulatory Challenges
As Minovia moves into Phase 3 of its clinical trials, compliance expectations will become even more rigorous. But thanks to ZenQMS’s robust document control capabilities, the team feels ready to meet tighter timeframes and higher compliance standards.
While GxP regulations continue to evolve, Minovia’s core document control and training processes are now built to scale, ensuring that staying compliant doesn’t slow down innovation. The team’s main focus is aligning the organization and preparing it for more rigorous approval timelines.
If you’re ready to see how ZenQMS can streamline QMS document control, improve efficiency, and stay ahead of compliance changes, schedule a demo today!