After recognizing that its home-grown data systems were inefficient, insecure, and non-compliant with 21 CFR Part 11, imaging-equipment manufacturer ACIST Medical Systems decided to upgrade to TrackWise from Sparta Systems, Holmdel, N.J., (spartasystems.com). The data-management system lets the manufacturer improve its efficiencies and compliance. For instance, automatic notification, distribution, and record assignment has reduced the time-to-closure for complaints, and let ACIST complete investigations ahead of its 30-day goal. Reports from the software provide accurate and up-to-date information to authorized users on demand.

TrackWise was deployed for managing failure investigations, material-review-board issues, and corrective and preventive actions (CAPA). The system provides a mechanism to manage root-cause analysis and to let staff know which CAPAs are assigned to their areas.

ACIST's home-grown quality systems used Microsoft Access databases, Excel spreadsheets, and paper forms. A lack of centralization in its disparate systems led to growing difficulties obtaining accurate and reliable information on a timely basis, particularly for complaint management.

While designing the initial workflow, ACIST personnel identified bottlenecks in its business process and designed TrackWise to streamline the workflow. Implementation with validation and training completed in just four months. What's more, eliminating manual data gathering, code changes, monthly report consolidation and other labor-intensive processes has cut four to six hours per person per week for key system users. Data is now secure, validated and 21 CFR Part 11 compliant. And customer service improved to the point where service-contract-renewal rates for the company's imaging equipment have increased to 90% since implementing the process.