Beacon Therapeutics: Preparing for Commercial Launch with a Lean QA Team & Configurable QMS

Beacon Therapeutics is preparing to bring a gene therapy treatment through pivotal Phase III trials and into the commercial space. But the journey hasn’t been linear. After selling off its internal manufacturing operations, Beacon restructured its business model and its Quality Management System (QMS) to support outsourced manufacturing and testing. The company depends on ZenQMS to maintain control, improve workflows, and stay inspection-ready.

“ZenQMS continues to show it’s up to the task. It meets us where we are. And where we’re going.” - Josh Guthrie, Quality Systems Specialist, Beacon Therapeutics

Rebuilding Quality Systems After Major Change

Beacon once manufactured its own drug substance and cell banks in-house. But following a business acquisition that included the transfer of their facility and manufacturing personnel, the company pivoted to focus exclusively on clinical development and sponsorship. That meant restructuring the QA team, revamping the QMS, and reassessing their quality system needs. 

“Beacon went through a big change in scope. We used to manufacture internally, but now we outsource all our production.”

With ZenQMS already implemented for documents, training, issues, and change controls, the foundation was in place to support the new model. The existing configuration served as a starting point, and handoff from the previous admin helped new staff hit the ground running. 

“I had a great trainer from the previous team who did a full brain dump – how everything was set up, what was validated, and why. That made a big difference.”

An Easy-to-Use Quality Management System That’s Just as Easy to Train 

With experience across multiple quality systems, including MasterControl, Josh noted that ZenQMS stood out for its straightforward interface, intuitive design, and lack of unnecessary jargon. 

“Other systems require you to learn their lingo – Zen doesn’t. That makes onboarding and training so much easier.”

For a small team tasked with training new users and cross-functional collaborators, that simplicity translates to efficiency. Whether updating document metadata, routing documents, or managing training assignments, Josh and his team were able to train users quickly and keep processes moving. 

“I’ve heard from multiple people that it’s simple and easy to pick up, especially compared to other systems they’ve used.”

Deviations and Change Controls That Fit Their Scope

In late 2023, Beacon expanded its ZenQMS implementation to include deviations, CAPAs, and change controls, replacing a paper-based system with digital workflows. While the team has fewer records now due to their outsourced model, ZenQMS gives them the structure to track and improve critical processes.

“Even when I first joined as a contractor with minimal training, I found it easy to jump into the system and start managing a deviation right away.” 

When working with Change Controls, Deviations, and CAPAs, Josh relayed how easy ZenQMS makes it to link related documents, update specifications, and maintain traceability across workflows. 

“Everything talks together. I could update a spec and link it back to the deviation – it all stays connected.”

Now, Beacon is iterating those workflows to better align with their current operations and future commercial goals. 

“We’re refining those workflows now by updating fields, improving controls, and making it better aligned to how we work.”

An Insights Module That Makes Audits Simpler

With a Quality Management Review (QMR) on the horizon and an internal audit recently completed, reporting and data gathering are top of mind for the team. ZenQMS Insights has quickly become a go-to tool for pulling metrics and visualizing key trends. 

“Insights and full table views make pulling metrics for QMR fast and easy. We can slice the data however we need to – month by month, quarter, whatever.”

In one case, the clinical QA team used the training dashboard to generate documentation that satisfied audit findings around training compliance. Rather than assembling records one-by-one, they used export tools to produce a clean, comprehensive view of training assignments and completions. 

“That would’ve been a lot more manual work before. Insights has saved us serious time.”

Josh also noted the value of backend reports available through user settings, making it easier to view course-level data and user assignments without having to dig through each record individually.

Positioning a QMS for Commercial Readiness

With a therapeutic headed toward commercialization, Beacon is taking proactive steps to lock down permissions, refine workflows, and archive legacy documentation no longer aligned with their operations. ZenQMS is enabling them to do so with precision. 

“We’re going through the system now to lock down permissions and archive what’s no longer relevant. The tools in Zen make that easy.”

Features like enhanced document visibility and permission controls are helping the team tighten access where needed and prepare for the stricter expectations of commercial manufacturing. 

“We implemented Zen when we were in the research phase. Now we’re getting it commercial-ready. The system has the flexibility to support both.”

Their quality plan outlines projects focused on system improvements, tighter controls, and scalable processes – all supported by ZenQMS. 

“Whether we’re supporting new users or refining our workflows, ZenQMS meets us where we are. And it’s positioned to grow with us as we go commercial.”

Discover how ZenQMS can simplify quality management for your team, regardless of your size or stage. Take 3 minutes to see the platform in action: Watch the Demo.