Case Study: Beacon Therapeutics prepares for commercial launch with ZenQMS

Beacon Therapeutics - Customer Case Study

Beacon Therapeutics, an ophthalmic gene therapy company founded in 2023, needed to rebuild its quality systems after shifting from in-house manufacturing to an outsourced CDMO model. As it prepared for pivotal Phase III trials and commercial launch, the lean QA team needed a configurable QMS that could support document control, training, issues, and change management while keeping the business inspection-ready.

Beacon Therapeutics implemented ZenQMS to maintain continuity across its quality processes and expand into deviations, CAPAs, and change controls. ZenQMS helped the team simplify onboarding, link related records for better traceability, and use Insights reporting to pull audit and training metrics much faster, saving significant manual effort. With stronger permissions, tighter workflows, and scalable controls, ZenQMS is helping Beacon prepare its QMS for commercial readiness.

Beacon Therapeutics

Josh Guthrie

Quality Systems Specialist