OPEN-SCS organization was founded by well known pharmaceutical companies and serialization solution providers, including Abbott, Advanco, Antares Vision, Omron, Optel Vision, SAP, Systech, TraceLink, Teva Pharmaceuticals Industries, Werum and WIPOTEC-OCS.
Driven by a growing number of member companies, the OPEN-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The OPEN-SCS Working Group (OPEN-SCS) is partnered with the OPC Foundation 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 their product packaging lines. This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management).
Over 40 subject matter experts presented and discussed in three different work streams the strategic and technical deliverables for the forthcoming release of the v1.0 OPEN-SCS. Three work streams covering the areas of the Technical Specification Committee (creating documentation according to GAMP), Technical Implementation Committee and Steering Committee addressed the main subjects and ensured a swift procedure. Additionally the group made a huge progress for Voting Draft Release and defined the go to market strategy. The team – including four guest attendees from global pharmaceutical companies as potential new members – determined clear deadlines and decision lists regarding the official release date scheduled in September.
“I am very content with the spirit and hard work put in by each member of the group and to see that so many vendors are working closely together. Looking at the progress of the different project it becomes clear that we work at lightning speed compared with other groups”, states Marcel de Grutter, Executive Director OPEN-SCS and Liaison Regulatory and Government Affairs at Abbott.
Even if some discussions regarding critical steps are hard and tough, the working group members achieved their milestones and agreed on conclusions. The process for building a professional organization is continuing and will soon be visible in an official certification program.
“The philosophy of open standard interfaces and interoperability are core values for all the working group members such as WIPOTEC-OCS. Therefore, it was a pleasure to host this meeting and to see very positive results of our activities”, added Volker Ditscher, Steering Committee Member OPEN-SCS and Business Manager Track & Trace at WIPOTEC-OCS.