Case Study: ACIST Medical Systems achieves secure, compliant quality management with Sparta Systems TrackWise

ACIST™ Medical Systems From Unmanageable Applications to Integrated Compliance with TrackWise

ACIST Medical Systems, a manufacturer of contrast injection systems used in operating rooms, radiology, and cardiac labs, was struggling to manage quality processes with Microsoft Access databases, Excel spreadsheets, and paper forms. As the company grew globally, these disconnected systems made complaint handling, MRBs, CAPAs, and incoming inspections difficult to manage, with limited visibility, slow information flow, and compliance concerns. ACIST selected Sparta Systems and its TrackWise quality management software to replace the homegrown approach.

Sparta Systems implemented TrackWise first for complaint management, completing validation and training in four months before expanding it globally and to other quality applications. The solution improved secure, timely information sharing across U.S., Europe, and Asia sites, streamlined workflows, and increased efficiency; ACIST reported reduced complaint response and closure time along with significant support savings. TrackWise was later extended to failure investigations, MRB issues, CAPA, training, device installations, and contract management, giving management better reporting and visibility.

ACIST Medical Systems

Plarent Ymeri

Project Manager