Vantage Consulting Group, a trusted manufacturing automation expert, today became the first systems integrator to join the pharmaceutical industry group working to enable seamless data exchange among serialization technologies.
The industry group, called the OPEN-SCS (Open Serialization Communication Standard) Working Group, is dedicated to helping the healthcare industry support the product serialization wave of the next decade, an effort aimed at patient safety, drug quality and healthcare affordability.
The group's work product, the OPEN-SCS standard and specifications, is designed to provide healthcare manufacturers and suppliers with a low-cost, scalable, secure and flexible integration platform for accelerating the deployment of packaging serialization solutions to meet the aggressive schedule of regulatory compliance through 2018.
Serialization means printing each saleable unit (e.g., carton, tray and individual bottle) and homogeneous shipper (case) with a unique identifier. It is a requirement of the Drug Supply Chain Security Act (DSCSA), the FDA regulation requiring pharmaceutical companies to begin serializing all prescription drug products intended for distribution to the U.S. market startingNov. 27, 2017, at the latest.
"Our clients in the pharmaceutical manufacturing space are currently facing significant technology and business challenges around serialization," said Rob Magee, portfolio director, Vantage Consulting Group. "These organizations, and ultimately consumers, will benefit immensely from an open communication standard and nonproprietary data exchange protocols. We're excited to bring our 'boots-on-the-ground' plant and supply-chain systems integration experience to this work and to, ultimately, help create a safer and more efficient supply chain."
OPEN-SCS is specifically working to standardize data exchange among pharmaceutical companies, packaging lines, equipment, distribution centers, warehouses and plant/warehouse operations, management systems and other supply chain players. A key goal is lower lifecycle costs through standards-based change management and global multi-plant/line scalability.
"OPEN-SCS is a critical initiative in pharmaceutical manufacturing and distribution, and its mission of rapid, cost-effective and streamlined serializationaligns entirely with our client commitment," said John Jordon, vice president of business strategies, Vantage Consulting Group. "We look forward to contributing our work, experience and insights to this essential cause."
OPEN-SCS is a partner of the OPC Foundation for standard data exchange in industrial automation and other industries. OPC is platform-independent and ensures the seamless flow of information among devices from multiple vendors. The OPC Foundation is responsible for the development and maintenance of this standard.
The OPC standard is a series of specifications developed by industry vendors, end-users and software developers. These specifications define the interface between Clients and Servers, as well as Servers and Servers, including access to real-time data, monitoring of alarms and events, access to historical data and other applications.