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A global designer and manufacturer of sophisticated medical devices needed a system to better manage its business process for addressing adverse events. It also needed to comply with a requirement from the Food and Drug Administration (FDA) for Corrective and Preventive Actions and to control product quality. The company asked Cognizant to lead its new quality management initiative.
After analyzing the company’s risky approach to data management using multiple applications, Cognizant Digital Business proposed a strong, centralized analytical platform that would decrease operation risks and production downtime. Using PTC’s ThingWorx Navigate and Windchill platforms, we developed a single data management system with a centralized governance program, providing a single source for verifiable data. This system enables data validation, monitors data ownership, creates audit trails, addresses adverse events quickly, tracks key performance indicators and manages user access privileges.
The system also provides access to data and reports on quality events. Users select the type of report required, and the system displays key information graphically as well as drill-downs on any data points for detailed analysis.
The client now runs a single decision-support and analytics system, reducing its reliance on point-solutions and paper-based processes. Cognizant’s rethinking of the way digital can be leveraged to better manage information is a model for how a digital enterprise can impact operations in a favorable way.
occurrence of compliance and risk events
response time from 20 days to less than a week
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