Case Study: Biorasi streamlines quality processes with ZenQMS

From implementation to operation, CRO Biorasi enjoys seamless Quality processes with ZenQMS

Biorasi, a global CRO, needed a better way to manage quality as it expanded internationally. Using a manual paper-based QMS and a cumbersome LMS made controlled document updates, signatures, and training assignments slow and difficult, while also requiring compliance with 21 CFR Part 11 and Annex 11. To solve this, Biorasi chose ZenQMS, an electronic quality management system (eQMS).

With ZenQMS, Biorasi streamlined document revision, approval, e-signature, and training release into a single workflow, reducing controlled document processing from hours to a click of a button. ZenQMS also supported the migration of thousands of training records and hundreds of controlled documents, and the implementation was completed in 90 days. As a result, Biorasi gained a faster, more flexible, compliant quality process and improved operational efficiency.

Biorasi

Christopher Culver

Quality Assurance Manager