Oracle has launched its Pedigree and Serialisation Manager (OPSM) software application designed to help pharmaceutical manufacturers implement mass serialisation and traceability of their products.
Serialisation is seen as a way for drugmakers to defend their products against counterfeiting and diversion by allowing packs of medicines to be tracked through the supply chain or at least verified at the point of dispensing.
Oracle’s platform comes at a time when pharmaceutical manufacturers are starting to upgrade their packaging lines to accommodate serialisation initiatives in a number of countries around the world.
A number of national serialisation initiatives are already in place in Europe and neighbouring Turkey, while other countries such as the USA, Brazil and China are also working towards this objective.
Meanwhile, various states in the USA as well as the federal authorities are looking into the feasibility of implementing a more comprehensive ePedigree-type system – involving a non-repudiable, electronic provenance document that would follow a product through the supply chain, recording the chain of custody and ownership.
Oracle says its new platform can handle either model and will “reduce business and reputational risk associated with the rising incidence of drug counterfeiting and product diversion while extending value across the pharmaceutical supply chain.”
The OPSM application generates serial numbers for products, stores the data and transmits and authenticates it as pharmaceutical products move across the supply chain, says Oracle.
It is built on the company’s core Fusion middleware software and a service-orientated architecture (SOA) to ensure it can be integrated into any enterprise software platform.
The application is also Web- and cloud-friendly with a user interface designed to let managers quickly view and access the entire life history of any given unit of medicine.
Benefits outside of supply chain security include making product recalls more efficient and reconciling product returns against product shipped.
“Ensuring supply chain integrity is not only about compliance and protecting your brand, it’s also about protecting your bottom line,” said Oracle’s Jon Chorley.
“By definitively identifying your products in the supply chain and providing a broad set of analytic insights on that data, OPSM will deliver both.”
Source:http://www.securingpharma.com/40/articles/536.php
