Case Study: Xpress Biologics achieves cGMP compliance and audit readiness with ZenQMS

ZenQMS helps European CDMO Xpress Biologics stay cGMP compliant

Xpress Biologics, a Belgian CDMO focused on biologics development and manufacturing, was struggling to manage paper-based training records and quality documents as the company and customer base grew. The manual approach made compliance, traceability, and audit preparation increasingly difficult, creating the need for an electronic quality management system. ZenQMS was selected to help Xpress Biologics maintain cGMP compliance and improve control over documentation and training.

ZenQMS implemented its eQMS platform, including the Documents and Training modules, giving Xpress Biologics centralized access to training materials, easier evidence sharing during customer audits, and a clear dashboard for tracking assignments. The robust validation package and Sandbox environment helped speed implementation and validation, while the system’s search and workflow tools improved efficiency and visibility. As a result, Xpress Biologics became more audit-ready, improved training compliance, and reduced the administrative burden on its quality team.

Xpress Biologics

Isabelle Renson

QA Officer