Rockwell Automation Introduces Its New Holistic Serialization Solution for Anti-Counterfeiting Regulatory Compliance

Rockwell Automation has introduced its new holistic serialization solution to help manufacturers comply with Anti-Counterfeiting Regulatory Compliance regulations. Proliferation of dangerous counterfeit medication is a global concern. Impending regulations across markets will require pharmaceutical, medical device, and consumer packaged goods manufacturers to trace products down to the individual saleable unit across the supply chain.  The new offering can help strengthen supply chains and help produce business benefits beyond compliance.

The holistic serialization solution, powered by Rockwell Automation's PharmaSuite MES software, is integrated across all four enterprise and control system levels of the ISA-95 data model. The solution leverages the Microsoft Azure cloud-computing platform and services, and connects and shares data. Data is shared between the plant floor, the enterprise, supply-chain partners and the retail point of sale, and potentially to the customer. The common serialization data thread, which provides real-time visibility to a company's products and customers, can help increase the efficiency and productivity of departments in The Connected Enterprise, such as manufacturing, quality, finance, supply chain, logistics and marketing.

Many existing "black box" serialization solutions were custom developed, created at the machine or enterprise levels. These systems often result in integration challenges with batch, processing, or plant-level systems, and can be difficult to maintain long-term.  Rockwell Automation's holistic serialization solution is designed for interoperability across each level. That includes integrating with different controllers, networks and serialization devices on the production line, as well as with MES and ERP systems at the site and enterprise levels.

As a standard solution, the system integrates into existing production lines to help minimize production interruptions and validation burdens. Additionally, Rockwell Automation offers remote-support capabilities, including real-time diagnostics monitoring and application-level support, to help minimize potential downtime.

The holistic serialization solution uses a GS1 Electronic Product Code Information Services (EPCIS)-certified platform from Covectra Inc. of Westborough, Massachusetts. The EPCIS-certified platform provides global serial-number generation and supply-chain event repository data management with applications that also include downstream track and trace, consumer authentication, patient adherence and patient outcome monitoring.

Keywords: Serialization platform, Device-To-Cloud Interoperability, ISA-95, Microsoft Azure, Cloud-Computing, ARC Advisory Group.