The Value of Standardized Data
The combination of legislation requiring ePedigree and item-level serialization is forcing the industry (at least in the United
States) to adopt a common standard for data exchange. Simply stated, data exchange is the transmission and receipt of information
through a computer-linked network. The information that one entity is passing on to another must be readable, and transferable
without question through the fastest means possible. Translational complexity can slow down the data exchange, and in some
cases even make it impossible to send and receive data, which would not comply with the necessary steps for pedigree.
All organizations in the supply chain will need to install new systems, software applications, and hardware components to
capture, expose, and exchange requisite data. Specifically, since every change of ownership will require the exchange of item-level
product, shipment, financial, and other data in an ePedigree file, all parties must be able to extract such data from multiple
legacy and Enterprise Resource Planning (ERP) systems. Once extracted, exchanging data with the other parties in the chain
via an electronic product code information service, or EPCIS (the global standard for automating the exchange of RFID data,
allowing cross communications), requires flexibility and standardization for an optimized result.
Although the means to exchange electronic data have been in place for quite a while—EDI 867 and 852 being among the most common
standardized data exchange formats—there is no common standard regarding the kind of data that should be exchanged between parties in the life sciences value chain. For instance, a specific segment of the industry value chain
may "blind" some data, so that not all sales transactions are fully transparent. Moreover, since EDI (electronic data interchange
documents—the business data documents exchanged from one organization's computer application to another trading partner's)
are not legal documents, companies have no incentive to certify that the data are accurate and complete. Standardizing the
data that must be transferred by all entities in the supply chain (along with a standardized format) will help clarify this
issue and facilitate monitoring of the three main elements involved in the passage of goods through the supply chain: the
flow of the physical product, transactions, and money.
Several companies are on the road to achieving digitization of their supply chain. For some time, these companies were the
exception, as most stood on the sidelines awaiting the 2009 date change, thinking and/or hoping that the mandate for pedigree
would just go away. Now, with a new deadline, the industry is seeking road maps to comply with the 2011 deadline.
Going with the Flows
For these companies, it will be important to build in flexibility, as federal and international requirements will surely require
changes to the core California compliance systems. Many countries are also trying to implement their respective versions to
safeguard citizens, and until standards are set, changing dynamics will impact multiple supply chains globally. This flexibility
is the most difficult part of the process, and could very well be where many in the industry stumble.