Officials from Apriso, a leading provider of manufacturing software solutions, announce a new extension to its Global Trace and Genealogy (G-TAG) software and services solution tailored to meet the specific industry requirements of Medical Device manufacturers. Apriso's new offering enables greater operational flexibility by delivering timely, contextual manufacturing intelligence and product genealogy data. This new solution helps to accelerate compliance initiatives and improve both in-house and supplier quality performance throughout the life cycle of a product, ultimately helping to reduce the total cost of quality.
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
Drived from Apriso's FlexNet, Apriso's G-TAG solution capabilities are a scalable process-based architecture ideal for medical device manufacturing. Designed to track genealogy and packaging hierarchies, the solution is 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," states Rick Gallisa, industry director – life sciences, Apriso.
Latest from Today's Medical Developments
- Kitov AI Inc., FANUC America partner to advance AI-driven smart manufacturing solutions
- Discover cutting-edge machining at SW North America's Open House
- Maximize efficiency: ROBOGUIDE V10's high-performance upgrades
- #47 Lunch + Learn Podcast with INSACO
- USC engineers develop groundbreaking wireless implant for chronic pain management
- WALTER tool making and measuring line: VISION LASER
- Holistic development of medical devices
- Mitutoyo unveils hybrid Hybrid FORMTRACER Avant H-3000 and Formtracepak v6.2 software for precision measurements