As international and local regulatory and traceability requirements have become increasingly stringent, the challenge to remain cost effective in compliance has become more difficult. Medical Device manufacturers must simultaneously improve responsiveness, increase tracking and performance measurement, reduce costs and maintain quality while operating under more complex, global regulatory conditions.
Gartner suggests to medical device manufacturers:
Apriso’s new G-TAG solution for Medical Device manufacturers provides a centralized repository and framework for collecting and storing all product genealogy and traceability data from internal systems and supply chain partners. This enables better data governance and the standardization of both structured and unstructured data that allow for compliance to emerging Track & Trace standards, achieve greater inventory visibility and more accurate order fulfillment, and of course, drastically improve life cycle management, and adverse event and recall management. As a result, G-TAG can directly impact two of the most pressing issues in the industry today: compliance with emerging regulations, and the costs associated with traditional compliance measures, which can exceed 30% of Cost of Goods Sold.
Specific capabilities include:
● Supply chain synchronization to better connect those involved in analyzing and taking corrective actions on quality issues for more timely resolution
● Standardized data in a single repository to more readily monitor quality and analysis performance so corrective actions can be identified and managed for efficiently
● Global access to electronic device history or batch records, offering better insight into managed quality activities and manufacturing operations
● Unified communications features to improve collaboration between users connected inside the firewall or their trading partners
● Workflow automation between suppliers and internal systems to faster contain issues and take corrective actions
Apriso’s G-TAG solution capabilities are derived from Apriso’s FlexNet, a scalable process-based architecture ideal for medical device manufacturing. The solution is designed to track genealogy and packaging hierarchies at a highly granular level, helping to ensure better data standardization while delivering the many benefits of a product genealogy solution (http://www.apriso.com/
“Medical Device manufacturers can benefit by implementing Apriso’s new G-TAG solution with a lower cost of compliance and product quality. These cost reductions can be achieved through more timely visibility and responsiveness to product quality issues across the product’s life cycle, including recall management,”