Case Study: Global Medical Technology Company achieves streamlined compliance and increased transparency with Sparta Systems' TrackWise

Sparta Systems TrackWise enables a large medical device company to streamline compliance and increase transparency

A global medical technology company that manufactures devices, instruments and diagnostic products needed to strengthen quality oversight, reduce the Cost of Poor Quality and improve regulatory compliance across a diverse, global product and customer base. Facing FDA scrutiny and recurring manufacturing issues, the company developed an Integrated Quality Strategy (IQS) and sought a software solution to align people, processes and technology for more transparent, cross‑functional CAPA management after its previous system proved inflexible and lacked multi‑language and help‑desk support.

The company selected Sparta Systems’ TrackWise EQMS for its configurability and workflow capabilities, then rolled it out in phases—piloting at five sites, expanding to 20+ sites and bringing more than 60 sites live within a year. The implementation required minimal customization, streamlined CAPA and compliance processes, increased transparency, and set the stage for broader TrackWise use in audits, change management and document control.