This article introduces us to the issues of drug counterfeiting and diversion problems and stringent legislature for Pedigree requirements from State and Federal government. We also propose an approach using an RFID based solution to address these problems. Though some of these issues reflect the global nature of procurement and proliferation of piracy some have come in the wake of tightening legislation, for example Florida item-level serialization and e-pedigree requirements coming from California.
We propose a tactical and strategic roadmap leveraging current investments in RFID to reap benefits from the investment in the future. By using serial and lot genealogy, companies can tag, trace and measure the progress of their goods throughout their lifecycle, even through the reverse supply chain - returns, refurbishments.
In the US Pharmaceutical, Life science & Biotechnology Market, Counterfeits & Diversions (Marketed & Distributed target market mismatch) pose a major problem in identifying that the correct product is received by the buyer. In addition, Pedigree & Serialization Vision & Legislature is also starting to clamp up to ensure that products are tracked and authenticated through the supply chain. This means that companies have to tag and trace each product/lot as it moves from Source to Destination or Consumption in some cases. In addition to issues like damage, loss etc, there is the additional problem of Genuineness of the product when it is eventually received and that there has been no tampering or fraud.
RFID applications which have the capability to store, cross reference, track, maintain an audit trace and authenticate the product, whether through serial, lot or case tracking and tagging will provide the most efficient long term solution for all geographic, economic, trade and physical requirements. Genealogy, the act of tracing a product from production to assembly and beyond is a capability that is required in order to be able to perform the required tracking, in addition, event driven tracking actions can also be used to determine shipping, transportation exceptions.
Coupled to Partner data interchange where the EPC is linked to an ASN, the same system can be used to validate authenticity of goods during receipt. Of course the authentication issue is rather best solved by a standards body and a proposal much like PGP of encrypting the code is one of the discussions on how to resolve this. the EPC Standards body could be proposed to be the holder to partner encrypting and decrypting keys which can be used to authenticate lots or serials as they are read. This undoubtedly places a burden on the application that is processing the tags and also opens up questions as to how to enable the dual purposes of event, location awareness with authentication.
Oracle RFID Logistics solutions provide customers with a proven Edge Server platform, BPEL capabilities embedded in the SES and Solutions with Oracle Supply Chain Execution products. The logistics applications allow tagging and tracking from manufacturing to assembly to distribution and shipping, while SES allows for flexibility, BPEL driven implementations with a view for the future. For more details refer to O.com and the section on RFID and Supply Chain Execution products.
Hope you find this first post interesting and food for thought.
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