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: “Justify track-and-trace investments through tangible benefits, such as efficient compliance, with serialization and authentication requirements, or enabling inventory management and order fulfillment at downstream customer locations,” as stated in their “Track and Trace: A Healthcare Value Chain Pulse Check” report (ID#G00209860), written by Wayne McDonnell, Hussain Mooraj and Fenella Scott in February 2011.
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. G-TAG uniquely synchronizes and tracks business processes spanning manufacturing, warehouse and quality operations – both within FlexNet and other third-party applications – on a global scale to facilitate greater collaboration across business units and trade partners.
“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,” said Rick Gallisa, Industry Director – Life Sciences, Apriso.
About Apriso Corporation
Apriso is a software company dedicated to helping its customers transform their global manufacturing operations. It does so by enabling manufacturers to achieve and sustain manufacturing excellence while adapting quickly and easily to market changes. Apriso's FlexNet is a BPM platform-based software solution for global manufacturing operations management. Apriso supports global continuous improvement by delivering visibility into, control over and synchronization across manufacturing and the product supply network. Apriso serves nearly 200 customers in 40+ countries across the Americas, Europe, Asia and Africa. Medical Device customers include Stryker Spine, Trixell, Becton Dickinson, Terumo Medical, Wright Medical Technologies and Johnson & Johnson. Learn more at: http://www.apriso.com. Visit our blog at http://www.apriso.com/blog.