Case Study Overview
Quality Management System harmonization is one of the biggest challenges for global biopharma manufacturers. When multiple sites operate with inconsistent processes — from deviations to batch release — the result is inefficiency, compliance risk, and lack of visibility. This case study shows how GMP Bridge helped a global biologics manufacturer redesign and unify its Quality Management System across Europe and North America.
The Challenge
A global biopharma manufacturer operating multiple biologics production sites faced significant inefficiencies due to inconsistent Quality Management System (QMS) processes. Variations in deviation handling, batch release, and QA oversight created redundant documentation, slowed operations, and reduced visibility of Quality performance across the network.
