From Complexity to Clarity: GH Research Builds a Flexible Quality Management System With ZenQMS

Building a Scalable Quality Foundation with a Lean Biotech Team

GH Research is a small, fast-moving clinical stage biotech focused on developing a novel and proprietary combination product for the treatment of patients with difficult-to-treat depression. With just three people on the quality team and a global workforce of around 60, the company needed a flexible quality management system (QMS) that could adapt as their team grew – without overwhelming their team or slowing down operations. 

When Margaret McKee joined GH Research as the Head of Quality, her first task was to assess the company’s entire quality function, including people, processes, and tools.

“One of the first things I had to do right away was a gap analysis of our whole quality management system – everything from the resourcing to the QMS itself. What really struck me was that the system in place wasn’t being used. People just found it too complicated.” - Margaret McKee, Head of Quality, GH Research

At the time that Margaret joined, GH Research was using an eQMS that  wasn’t resonating with users, and critical-to-quality processes like change control were still being handled manually in SharePoint. And as GH Research was preparing to enter Phase III of clinical trials, Margaret needed a system that would drive adoption, compliance, and simplify QA oversight for her team. 

Fast to Implement, Flexible to Use, and Always Inspection-Ready With ZenQMS

After evaluating several QMS platforms, Margaret selected ZenQMS based on:

• Its intuitive user interface
• The ability to configure the system without IT support 
• Its track record of success with quality teams in growing organizations

The decision came at a pivotal time. Just as implementation kicked off, GH Research received notice of an upcoming inspection. 

To help manage the data migration from their previous QMS to Zen, GH Research brought on Avril Aylward, who had just joined as QMS Documentation Specialist.

“I had used Zen before and knew it could work for us. We needed something dynamic, easy to manage ourselves, and flexible enough to grow with us. That’s what ZenQMS offered.” Margaret McKee, Head of Quality, GH Research

Despite the high stakes, the team moved quickly. With structured templates for migration, GH Research was able to complete QMS implementation in 3 months and stay inspection-ready throughout. 

“The templates ZenQMS provided for implementation gave us structure, and the support team was incredibly responsive throughout the process. Even with the time difference, I’d get answers the same day. We had over 700 documents to migrate, and everything moved smoothly.” Avril Aylward, Senior Quality Specialist, GH Research

By the time the inspection occurred, GH Research had already gone live with the Documents and Training modules, laying a solid foundation for compliance. 

Smarter Change Control for a Complex Product

GH Research manages multiple streams of change across its business – from drug substance and product to devices, clinical trials, and organizational processes. The manual, form-based approach they had been using before Zen wasn’t scalable or consistent. 

“We needed different workflows depending on the type of change. ZenQMS gave us that flexibility.” - Margaret McKee, Head of Quality, GH Research

With ZenQMS, GH Research was able to:

• Define custom workflows for GH-initiated vs. vendor-initiated changes
• Categorize changes by business area (clinical, drug, device, organizational)
• Assign tasks with automated reminders and clear due dates
• Track progress to closure with full visibility

“Before, things could be forgotten. Now people are reminded, tasks are visible, and we don’t have to chase as much. Oversight has definitely improved.” - Avril Aylward, Senior Quality Specialist, GH Research

The result is a structured, auditable change control process that fits their combination product model without adding unnecessary complexity.

Document Management That Matches the Way They Work

A well-organized document structure is critical for GxP-regulated organizations like GH Research. With quality activities spanning multiple departments and systems, they needed to set things up in a way that aligned with how their team worked from the start. ZenQMS’s configurability made that possible.

To avoid confusion and support daily workflows, GH Research decided to align ZenQMS categories and Key IDs with their internal SOP and form number system. That required some initial effort upfront, but the clarity it created was well worth it.

Even with more document categories than typical organizations, GH Research’s structure supports faster onboarding, easier searches, and more intuitive system use across teams. 

Simple, Role-Based Access and Oversight

As GH Research grows, departments and responsibilities continue to evolve. Managing document permissions and user access needs to be fast, flexible, and handled internally. ZenQMS made that easy from day one. 

“When a new department is created, we set up a role and assign documents for training. It’s easy to manage ourselves, which is really important for a team our size.” - Margaret McKee, Head of Quality, GH Research

The quality team appreciates how easy it is to use the administration tools because it gives them full confidence to ensure compliance and make changes quickly without relying on IT or third-party support. 

An eQMS for Phase III Clinical Trials and Beyond

With ZenQMS, GH Research has built a scalable quality foundation that will support the increased complexity of Phase III clinical trials and future growth. Training compliance has improved significantly, and the team is now prepping to roll out the Issues and Audits modules next. 

“We need a system that scales with us and gives us control. We can’t afford to wait three months for someone else to make a change. ZenQMS lets us move at our own pace.” - Margaret McKee, Head of Quality, GH Research

The GH Research Quality Team is now positioned to meet evolving regulatory expectations, manage sponsor oversight requirements, and maintain visibility across the full spectrum of quality activities. 

GH Research transitioned from an underused system to a flexible quality management system tailored to the way they work. With ZenQMS, they’ve gained clarity, configurability, and confidence – without sacrificing speed or simplicity.

Want to see how ZenQMS can work for you? Watch our 3-minute demo for a quick look at simple and compliant quality management software.