How CDMO Create Biosciences Chose ZenQMS for a Scalable, Client-Ready Quality System

Delivering Scalable Quality in Life Sciences Manufacturing

As a contract development and manufacturing organization (CDMO), Create Biosciences helps life-sciences innovators bring complex products from concept to commercialization.

The company supports clients across early development, process development, and GMP manufacturing – all within a highly regulated environment where data security and compliance are inseparable from customer trust.

In this environment, quality isn’t just a compliance requirement – it’s a differentiator. 

Create Bio’s clients rely on the company to deliver not only consistent results, but also clear visibility into the documentation, data, and processes behind every product.

“We help life-sciences companies move from idea to scalable, stable manufacturing,” said Brian Van Hatten, CEO & Co-Founder. “That journey means quality has to evolve right alongside the product.”

The Challenge: Manage Quality Processes And Provide a Better Client Experience

Initially, Create Biosciences managed its quality program using paper records and a manual process. The approach proved initially effective; however, as manufacturing activity expanded, the client experience fell behind.

“We were using a folder structure inside something like SharePoint,” Van Hatten recalled. “It was very manual – a lot of drag-and-drop. That worked early on, but as our customers moved into manufacturing, the documentation became just as important as the product itself.”

For a growing CDMO, the problem wasn’t just internal efficiency. The company needed a quality management system  (QMS) that could scale and reflect well in front of customers, both critical to maintaining trust in a client-facing manufacturing model.

“We needed a system that not only worked for us, but also presented well to our customers.”

Selection Criteria: What Create Biosciences Needed in an eQMS

When the team began evaluating eQMS options, three priorities stood out:

• Ease of use – intuitive for both internal teams and client collaborators
• Configurability – flexible enough to match different customer and product workflows
• Scalability – able to support growth without adding headcount

“Cost mattered, but configurability and ease of use were the true drivers,” said Van Hatten. “Zen became an extension of us – clean, intuitive, and something we’re proud to show our customers.”

Why ZenQMS: Configurable, Scalable, and Client-Facing

As a CDMO, Create Bio manages multiple client products with unique process requirements layered on top of its own manufacturing standards. That variability demands a QMS that adapts – not one that forces a single rigid workflow.

“There are systems that say, ‘Here’s the workflow – you can’t deviate from it.’ That doesn’t work for us. The dynamic nature of our business requires configurability and ease of use, and Zen delivers both.”

ZenQMS stood out for its high configurability, allowing CDMOs like Create Biosciences to tailor the eQMS to their specific processes and forms without vendor intervention or costly customization fees.

Just as importantly, ZenQMS provided Create Biosciences with a digital system that effectively represents the company during customer audits, project reviews, and quality interactions.

“It’s not only about how our team manages quality. It’s how the QMS presents itself to our clients. That experience reflects directly on us.”

Implementation and Onboarding: Fast Adoption with Low Friction

Transitioning from paper to ZenQMS was simple and efficient.

The Create Bio team, experienced with ERP and LIMS systems, found Zen’s onboarding process refreshingly straightforward.

Key onboarding advantages:

• Rapid setup of document and change control workflows
• Minimal training time and quick user adoption
• Immediate visibility across quality and manufacturing teams

“You’re not trying to make someone an expert on day one, but Zen removes the initial barriers because it’s so intuitive.”

This intuitive, user-friendly design enables users to start working within the system almost immediately, a rare advantage for small teams that require speed and compliance without complexity.

Key Modules Powering Manufacturing and Audit Excellence

Create Biosciences now uses ZenQMS to streamline critical quality functions across its manufacturing operations:

• Change Control (ECO Process): Clients review and approve engineering changes directly within Zen, creating a single source of truth.
• Document Management & Non-Conformance: Teams can quickly locate controlled documents, track updates, and log deviations for complete traceability.
• Audit Management: Real-time access enables seamless collaboration between front-room/back-room personnel during ISO and customer audits.

“Maintaining an audit used to mean digging through folders. Now everything’s right there – it’s a game changer.”

Results: A Modern QMS That Scales and Builds Trust

Since adopting ZenQMS, Create Biosciences has replaced manual, paper-based processes with a modern, digital QMS that enhances efficiency, scalability, and strengthens client confidence.

ZenQMS enables the team to adapt to new products and clients without adding administrative burden, while presenting a professional, compliant quality framework during every engagement.

“Zen makes us more scalable as a team. It’s easy to configure, easy to maintain, and it reflects who we are – efficient and client-focused.”

For Create Biosciences, the return on investment of an eQMS is both reputational and operational. The system’s polish, speed, and flexibility now serve as an extension of the company’s commitment to its customers.

“You can find cheaper systems, but they come with hidden costs. We’d rather invest in something easy to maintain and scale than hire extra people just to manage it.”

Ready to see how ZenQMS can help your team scale with a flexible quality management system that’s purpose-built for life sciences organizations? Check out our 3-minute demo for a quick preview of the system.