Case Study: Large Medical Device Company achieves streamlined CAPA compliance and rapid 60-site global rollout with Sparta Systems' TrackWise

TrackWise enables a large medical device company to streamline compliance

A global medical technology company that designs and manufactures medical devices and diagnostic products faced persistent challenges managing corrective and preventive actions (CAPA) across a growing, international organization. Regulatory scrutiny, the need to prevent recurring manufacturing issues, and an earlier CAPA system that forced process changes (and lacked multilingual and help-desk support) made it difficult to align quality initiatives with the company’s Integrated Quality Strategy (IQS).

The company selected Sparta Systems’ TrackWise to reframe CAPA around people, process and technology and to standardize global workflows. TrackWise’s configurable, out-of-the-box functionality enabled a phased rollout—pilot at five sites, then 20+ sites, with more than 60 locations live within a year—delivering streamlined compliance, minimal customization, and plans to extend TrackWise to audits, change management and document control.