Holistic serialization solution for anti-counterfeiting regulatory compliance delivers added business benefits

The new holistic serialization solution introduced by Rockwell Automation is designed to assist manufacturers of pharmaceutical, medical
device and consumer packaged goods to comply with new traceability regulations.

The global proliferation of dangerous counterfeit medication has led to
new compliance regulations being introduced that will require these manufacturers
to trace products down to the individual saleable unit across the supply chain.

Powered by the PharmaSuite MES software from Rockwell Automation, the holistic
serialization solution is fully 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 seamlessly connects and shares
data between the plant floor, the enterprise, supply chain partners, the retail
point of sale, and potentially, right up to the customer.

The common serialization data thread, which provides real-time
visibility to a company’s products, can increase the efficiency and
productivity of all departments in The Connected Enterprise, from manufacturing,
quality and finance to supply chain, logistics and marketing.

According to Joe Whyte, global serialization lead for Rockwell Automation, companies
in the life sciences as well as many food, beverage and consumer packaged goods
segments must implement or upgrade track-and-trace systems to meet the growing
number of serialization regulations worldwide.

In addition to ensuring compliance for manufacturers, Rockwell
Automation’s new serialization solution helps them achieve real commercial and
business benefits including avoiding millions in inaccurate chargeback or
rebate payments; adding millions in revenue by eliminating gray market product
diversions; reducing the cost and improving the accuracy of product recalls;
and optimising manufacturing and supply chain inventories thanks to production
rates driven by real-time consumption data.

Unlike existing black box serialization solutions that cause integration
challenges with batch processing or plant-level systems, Rockwell Automation’s holistic
serialization solution is designed for interoperability across every level, 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.

The standard system integrates into existing production lines to reduce
production interruptions and validation burdens. Rockwell Automation also offers
remote support capabilities, including real-time diagnostics monitoring and
application-level support, to help minimise 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 business benefit applications that include downstream track and
trace, consumer authentication, patient adherence and patient outcome
monitoring.

Rockwell Automation is collaborating with Strategic Alliance Partner
Microsoft, a valued member of the Rockwell Automation Partner Network program,
to deliver cloud-based, remote monitoring services and information solutions to
bring together business and manufacturing intelligence worldwide.