Having just completed a meeting in Princeton, NJ, and with another one scheduled in Germany next month, the Open Serialization Communication Standard (Open-SCS) Group is cranking up to deliver a usable standard for life sciences companies implementing serialization technologies for tracking pharmaceuticals through national and international supply chains. And that’s not a moment too soon, since pharma companies are already installing the hardware and software necessary to meet the November 2017 deadline of the 2013 Drug Supply Chain Security Act (DSCSA).
It’s ironic, but in the 10+ years that serialization (the process of putting a unique ID code on each package of pharmaceuticals coming off a packaging line) has been proposed, withdrawn, re-proposed and now mandated in the US, the EU and much of the rest of the industrialized world, few people paid attention to how serial data would be communicated from what is now called Level 3 (a manufacturing or packaging site) to Level 4 (the enterprise, and from there to trading partners). As a result, the growing number of serialization software vendors have been building interfaces to each other’s systems (or obligating their clients to do so). Leading vendors tout the quantity of interfaces they have built or installed (thus, offering a potential competitive advantage relative to other vendors); with a standard, however, the potential exists to make those interfaces a matter of routine implementation. Open-SCS also plans to address other automation levels such as between packaging lines and sites.
“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 Open SCS and IT business relationship manager at Abbott, in a statement. “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.”
To the degree that this standardization is important to a manufacturer acquiring serialization technology, there is now a qualitative difference between the companies participating in Open-SCS and those who are not. Current membership is 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 (interestingly, the OPC Foundation Open-SCS page lists SAP as a member, but the just-issued news release does not).
There’s an interesting evolution to how Open-SCS came into being. Early discussions at Optel Vision and Systech led to a call for a neutral, industry-wide organization, but rather than starting one themselves, the early participants sought out an existing standards-setting body. Enter the OPC Foundation, a group set up many years ago for industrial automation communication standards, and has promulgated standards for both automation processes and for automation data. For whatever reason, the GS1 organization, which has established the EPCIS standard for how serial data gets exchanged between organizations, was not the right place for this more automation-specific standard.
More information on Open-SCS is available here.