Serialisation standard group makes progress towards uniform track & trace standard

Aims to standardise serialisation data exchanges across production and warehouses

Open-OCS Group aims to standardise serialisation data exchanges across production and warehouses, and the interface to enterprise supply chain systems

The Open Serialisation Communication Standard (Open-SCS) Group, a collection of firms operating in the healthcare sector dedicated to standardising packaging line serialisation and aggregation data exchanges, is making progress in its goal of drafting a core set of industry wide serialisation standards.

Founded last year, Open-SCS is an initiative driven by serialisation specialists to address the wave of regulations that will affect the healthcare sector in the next decade.

Group members include Advanco, Antares Vision, OCS, Omron, Optel Vision, Systech, TraceLink and Werum IT Solutions.

Global pharmaceutical manufacturers such as Abbott, Johnson & Johnson, Pfizer, Roche and Teva are also members.

Several new companies – both vendors and end users – will join the group in the near future, Open-OCS Group said.

The Open-SCS Group’s goal is to develop an open source standard in the Packaging Serialisation Global Name Registry, and an associated set of subscription-based work products.

An open communication standard that is independent of proprietary architectures and data exchange protocols provides a significant advantage for pharmaceutical manufacturers

The open standard and work products are focused on the standardisation of data exchanges for healthcare packaging serialisation and the aggregations between a healthcare provider’s enterprise serialisation management system and its product packaging lines.

This includes interfaces between packaging levels of automation (equipment, line, plant), supply chain (distribution centres, warehouses, CMO operations) and notification to regulators.

The Open-SCS Group is currently working to create communication specifications between Levels 3 and 4 (plant versus enterprise repositories).

'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 serialisation solutions to meet emerging track and trace regulations,' said Marcel de Grutter, Executive Director 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.'

Tom Burke, President and Executive Director of the OPC Foundation, added: '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 realising the benefits of the Internet of Things (IoT) across the pharmaceutical serialisation ecosystem.'

The standard, once published, will be free for anyone to use.

A new draft Feasibility Study is now available.