Open Serialization Communication Standard Group Makes Progress Toward Uniform Track and Trace Model

The Open Serialization Communication Standard (Open-SCS) Group, a collection of healthcare sector companies dedicated to standardizing packaging line serialization and aggregation data exchanges, is making steady progress in its goal of drafting a core set of industry-wide serialization standards, the organization reports following its latest gathering in Princeton, N.J.   

Founded last year, Open-SCS is an initiative driven by leading serialization solution vendors to address the healthcare industry’s wave of serialization regulations spanning the next decade.  Vendors comprising the group include Advanco, Antares Vision, OCS, Omron, Optel Vision, Systech, TraceLink and Werum IT Solutions.  The group also includes global pharmaceutical manufacturers such as Abbott, Johnson & Johnson, Pfizer, Roche  and Teva.  Several new companies – both vendors and end users – are expected to join Open-SCS in the near future.

In partnership with the OPC Foundation, the Open-SCS group’s ultimate goal is to develop an open source standard in the Packaging Serialization Global Name Registry, and an associated set of subscription-based work products.  The open standard and work products are focused on the standardization of data exchanges for healthcare packaging serialization and the aggregations between a healthcare provider’s enterprise serialization management function and its product packaging lines.  This includes interfaces between packaging levels of automation (equipment, line,  plant), supply chain (distribution centers, warehouses, CMOs operations) and – in perspective - notification to regulatory.

In its current phase, the Open-SCS Group is working to create communication specifications between Levels 3 and 4 layers (plant versus enterprise repositories), leveraging its combined experience deploying serialization platforms and interfacing with all common repositories and ERP solutions.

“An open communication standard that is independent of proprietary architectures and data exchange protocols provides a significant advantage for pharmaceutical manufacturers and other members of the supply chain, who are facing massive rollout of serialization solutions to meet emerging track and trace regulations,” said Marcel de Grutter, executive director of Open SCS and IT business relationship manager at Abbott. “The development and adoption of interoperability standards like those being developed by the Open-SCS Working Group greatly reduces risk and cost across the supply chain.”

“The OPC Foundation strongly supports this important standards effort launched by leading vendors and pharma companies across the global pharmaceutical supply chain,” said Tom Burke, president and executive director of the OPC Foundation. “The development and broad adoption of practical open standards has been our mission since day one and this effort will be a key foundation in realizing the benefits of the Internet of Things (IoT) across the pharmaceutical serialization ecosystem."  

Vendors are encouraged to contribute to the definition of use cases, while customers gain free access to a number of deliverables, including advanced packaging serialization User Requirement Specification (URS) for the proposed use cases.  The standard, once published, will be free for anyone to utilize.

Soure: Open-SCS Working Group