Case Study: Diagnostic Imaging Agent Manufacturer achieves reduced costs and centralized quality and compliance control with AssurX

A AssurX Case Study

Preview of the Diagnostic Imaging Agent Manufacturing Company Case Study

Reducing Costs and Centralizing Quality and Compliance Control with a Single Platform

A global manufacturer of medical diagnostic imaging agents was burdened by fragmented legacy quality systems that threatened product quality and regulatory compliance. Four separate QMS running on 18 servers, siloed and paper-based data, unstable applications, missing CAPA effectiveness checks and unautomated regulatory filings created escalating support costs, manual workarounds and delayed visibility into risk.

The company migrated and standardized quality processes onto the AssurX platform using a phased reassess/rebuild, integration and training approach—moving roughly 20,000 lifecycle documents and ~100,000 training records and deploying 16 core processes. Consolidation improved visibility and compliance and delivered significant savings: 65% reduction in server maintenance, 90% cut in licensing costs, 3,072 fewer personnel hours and $266,000 in first‑year hard cost savings, while expanding process coverage and user efficiency.


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