Monday, February 04, 2008
Electronic pedigrees coming to California
An e-pedigree is an electronic, auditable chain-of-custody record for pharmaceuticals from the point of manufacture to the point of sale. Paper-based pedigrees have been required since the passage of the Federal Prescription Drug Marketing Act of 1987 (PDMA). Although the FDA requirements for e-pedigree are stalled in federal court, individual states have moved forward with enacting their own legislation for compliance.
D -- data types and document types
O -- organizational transactions and processes
The entire supply chain is affected by this change. Each saleable unit must be identified and recorded at every stage as it moves from the supplier to the customer.
C -- context
All pharmaceutical products for sale in
U -- user types and special user requirements
Manufacturers must generate serial numbers and make each unit identifiable by any entity which will accept custody of the pharmaceuticals. The
M -- models, patterns, or standards that apply or that are needed
One possible solution is to utilize a Global Trade Identification Number (GTIN) mapped into a 96-bit encodable EPC ID number. The global standard developed by EPCglobal, ratified January 5, 2007 contains two XML schemas available: the electronic pedigree format for use with open document-based pedigree laws and the standard electronic envelope format for use in document exchange between supply chain partners.
E -- enterprises and eco systems
EPCglobal is a non-profit consortium developing standards for Electronic Product Codes.
N -- the needs (business case) driving the enterprise(s)
T -- technology constraints and opportunities
Besides compliance with
But, I sometimes thinking of the possibility that RFID could be a disruptive technology as mp3 displaced the record industry. Some Korean companies like Samsung and Hyundai are now adopting RFID tags for the automation of their factories. Since the tags can identify each item of a complete product, well-programmed robots can read RFID and automatically put each item where it is supposed to be inside the product. This case shows the possibility of almost perfect factory automation as well as the benefits of inventory management and transparent monitoring. I think RFID is a quasi-disruptive technology in this case.
So, it would be really interesting to image the RFID as a disruptive technology.
But it will good when this finally gets done... maybe by 2020.