Scale of deployment Most companies start with a limited deployment, so the e-pedigree system won't really be put to the test. Ensure that the software will perform at the level you require when fully rolled out and will do so without dramatically increasing costs.

Cost The cost to implement an electronic pedigree system will vary depending upon the size and complexity of a company's operations. The outsourced, software-hosted model is the most common way to deploy an e-pedigree system. Costs for a hosted e-pedigree solution that can provide complete pedigree security for all of a company's prescription drug products typically range from the low thousands up to tens of thousands of dollars per month.

Experience Nothing beats experience, so be sure the vendor has experience with other companies like yours, as well as experience with your trading partners.

Another road map step is developing an integration strategy. E-pedigree is a business process tightly connected with other existing processes. The introduction of e-pedigree presents an opportunity to improve and streamline both compliance and business processes.

You will need to know how and where the pedigree system will be integrated with processes such as shipping, receiving, and picking. The information required to populate the e-pedigree probably already exists in other systems within your IT infrastructure, and you'll need to map out what information is needed from which system, and how you will access it.

ERP and warehouse management systems will be prime integration points, but you will want to maximize the value of pedigree data collected by making it available to other business applications as well. Finally, you'll need to determine the right technical approach for integrating these systems.

The crucial last step is to work out how you will collaborate with your trading partners. Because e-pedigree is a supply chain process, interaction with your partners is necessary if the project is to succeed. What kind of information do your trading partners require in order to facilitate the implementation of e-pedigree? How will e-pedigrees be exchanged? How will exceptions be addressed? Testing with upstream and downstream partners will ensure that your pedigreed products will be in the channel in time to meet regulatory deadlines.

ePedigree Benefits

The immediate benefits from e-pedigrees are improved patient safety and the protection of product-revenue streams from diversion and counterfeiting. With e-pedigrees implemented throughout the drug supply chain, the means by which counterfeiters can introduce illegitimate products are virtually eliminated. Plugging the holes in the drug distribution network helps manufacturers stem the loss of revenues, profits, and brand reputations.

The next wave of e-pedigree benefits comes from efficiency improvements in manufacturing, distribution, and procurement. Paper pedigree overhead is eliminated and new levels of inventory control are gained.

The availability of lot, quantity, product shipment, and serialization information (if available) allows companies to track a specific drug product through the supply chain, enabling more targeted and expedited recalls, lowering the risk to patients, and reducing recall execution costs.

Each year, companies lose millions of dollars due to their inability to verify the validity of returns, chargebacks, and other financial reimbursement claims. By tapping into the secure and accurate product identification and channel-movement-transaction information within e-pedigrees and correlating this information with related trade financial documents, companies can improve the accuracy and efficiency of financial claims and curtail revenue leakage from inaccurate, duplicate, or inappropriate claims.

E-pedigrees trace the physical product flow through the supply chain for greater channel visibility, which improves product availability and lowers costs. With direct visibility into expiration dates and lot information contained within the e-pedigree, companies can better manage shelf life and expired products, improve supply chain visibility and product availability, and enhance trade financial management.

Peter Spellman is senior vice president of products and SaaS at SupplyScape. He can be reached at pspellman@supplyscape.com