We have joined the OPC group Open Serialisation Communication Standard (Open SCS) with the goal to standardise the communication interfaces between the different solution providers who provide solutions for the various global serialisation requirements.
To fight the immense market of counterfeit products and to enhance patient safety, several initiatives and legislation are in place or are emerging globally, such as the EU Falsified Medicine Directive (2011/62/EU), the DSCSA in the USA and other requirements in many countries around the globe.
Open SCS in the Healthcare Industry
Driven by Healthcare Providers, 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). The scope of the 2015/16 work products focuses on data exchanges for 6 proposed use cases in two data exchange categories: 1. Mandatory Services and 2. Support Services which are addressed in 6 common Packaging Line Serialization System Configurations.
Challenges and solutions
“As a packing line automation provider, we receive many requests from Pharmaceutical manufacturers and machine builders to realize handling, packaging and serialisation requirements”, said Gunnar Bischoff, our strategic marketing manager. “But often these requests have different preferences regarding the hand-shakes, protocols, communication interfaces and compliance management. All individual and special requests increase the cost and the time to realize solutions and the effort for version management and documentation.”
“An open communication standard that is independent of vendor specific architectures provides a significant advantage for Pharmaceutical manufacturers. It opens the possibility to bring more and the most suitable solution vendors into new projects. This not only reduces the risk for supply bottle necks and technology lock-ins, but also allows to re-use specification requirements and makes offers more comparable.”, said Marcel de Grutter, Executive Director Open SCS and IT Business Relationship Manager at Abbott. “We now see more and more manufacturers and vendors joining our initiative and a very promising alignment with various global standardisation stakeholders”.
About OPC and Open SCS
OPC is the interoperability standard for the secure and reliable exchange of data in the industrial automation space and in other industries. It 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.
Open-SCS is a commercial open source member subscription, combining the advantages of open source and the group membership allows members to efficiently and rapidly develop technology to deliver independent and open solutions. Open-SCS was founded with the mission of enabling member organizations to benefit from the open source ethos of a non-proprietary open standards and specifications built on innovation, independence and an open architecture.
For more information visit the Open SCS page.