How Vedanta Biosciences Uses ZenQMS for Issue Management and Change Control

Vedanta Biosciences is a start-up biotech company currently in phase II and III of clinical trials, preparing for commercial production. With a small but experienced Quality team, they needed a quality management system that could scale with them without slowing them down.

“We needed a quality system that was more flexible, something more in line with where we’re trying to go as an organization.” – Doug Ducharme, Director of Quality Assurance, Vedanta Biosciences

Why Vedanta Needed a More Flexible Quality Management System

Before moving to ZenQMS, Vedanta was already using an eQMS platform. But while the system was customized for their organization, it wasn't flexible. The platform worked, but it was difficult to make changes or update processes to adapt and trace records across workflows, or evolve quickly. As Vedanta prepared for commercial production, they needed something more configurable. Something that could scale with them.

“Part of the difficulties and challenges we had with our previous quality management system was that everything was compartmentalized. You had to open a different folder, tab, or go to a different document number to get certain things aligned and tracing back and forth. With Zen, once you start getting stuff together, you can link it, and it’s done. And you can link anything back and forth. There’s full flexibility there.”

In his 20 years of experience, Doug had worked with other quality systems and recognized the need for a compliant, more adaptable platform.

Choosing ZenQMS: A Configurable eQMS Without Vendor Dependence

When a colleague introduced him to ZenQMS, Doug immediately saw the value. Not only was the system validated and ready to go, but it was also flexible. This flexibility meant his team could:

• Build their own quality workflows
• Create custom fields in workflows
• Create custom issue categories
• Manage system updates

And they could do it all without having to rely on external support.

“One of the nice things about Zen is, once you get trained up on it, you can do it. We’ve built a lot of our own workflows and validated them into the system. You don’t need vendor support. That helps us curtail what we want to do and pivot much quicker.”

That ability to adapt, without sacrificing compliance, was exactly what Vedanta needed.

Issues and Change Control: Designed to Fit, Not Forced to Work

Issues and change control were two of the first modules Vedanta rolled out. Doug’s team built their investigation workflows from scratch, embedding expectations and directions for employees directly into each step to keep everything consistent and clear.

“The really nice thing about issues and change controls in Zen is that we were able to design them.”

That ownership made onboarding easier. Because the workflows were designed in-house, they reflected how the team actually worked. New employees didn’t have to adapt to rigid, unfamiliar structures. Instead, they were trained on intuitive steps aligned with Vedanta’s day-to-day processes, making it easier to get up to speed quickly. It also meant that the workflows worked exactly the way the team operated, rather than forcing a new structure imposed by a rigid, non-configurable system. As Vedanta moves toward commercialization, they’re continuing to refine and expand these workflows, with no need to start from scratch.

“We’re tweaking change control now as we ramp up. It’s continuous improvement, and it’s just simple to do in Zen.”

Linking Quality Records Across Modules for Full Traceability

A major pain point with Vedanta’s old system was how disconnected everything felt. CAPAs, deviations, and change controls often had to be tracked manually, sometimes requiring users to know the exact document number or navigate through multiple tabs just to find what they needed.

That changed with ZenQMS. Now, the team can link documents, deviations, CAPAs, and Change Controls with just a few clicks.

“I can hyperlink whatever I want. Change Control to a deviation. A CAPA to a document. It’s all connected. It’s not restrictive.”

That connectively makes audits easier, clarifies investigations, and eliminates the need for physical paper trails or backtracking. And as Doug’s team starts building out additional workflows – including internal tickets and audit prep – they’re extending that same clarity into new areas.

The Result: Faster Adoption, Better Visibility, and Room to Grow

Since switching to ZenQMS, Vedanta has seen rapid adoption, fueled by the fact that the workflows were built by the people using them.

“Even newcomers can get into ZenQMS and understand it. A big part of that is because we designed how it works, so it’s easy to teach.”

The system has also helped the team reduce their paper footprint and bring more structure to processes that were previously manual or inconsistent. From work orders to internal investigations, everything is being pulled into a single system that the team controls.

“Whenever you can get an electronic, compliant version of a paper process, it always helps. Makes it quicker, easier to navigate. And again, everything is connected.”

A Modern eQMS That Supports Commercial Readiness

With ZenQMS, Vedanta isn’t just maintaining compliance; they’re actively building a modern, connected quality system that’s flexible enough to grow with the business. By designing their own workflows, linking records across modules, and eliminating paper-based bottlenecks, the team has full control over how quality is managed today, and how it will scale tomorrow and adapt to the ever-changing compliance requirements within the industry.

“ZenQMS gives us the control to run quality the way we want to.”

For life sciences companies preparing for commercialization or simply looking to modernize, Vedanta’s story shows what’s possible with a flexible eQMS built for change.

Curious what that could look like for your team?

Watch our 3-minute demo to see how ZenQMS simplifies quality, connects your data, and puts you in control.