ePEDIGREE TRACKING

ePedigree Tracking. Every drug manufacturer is required to serialize drug products at the item, case, and pallet level to support the ability to generate a electronic pedigree (ePedigree) document to track, trace and authenticate the product from the time it is initially sold to a distributor all the way through the supply chain to the point of distribution. MAXLife simplifies and accelerates the ePedigree process from receiving through shipment, ensuring compliance with government regulations.
Back to Compliance and Safety

Since 2000, FDA criminal investigations of drug counterfeiting have increased sixfold. With the U.S. pharmaceutical market reaching annual sales of $200 billion, drug counterfeiters have become highly sophisticated, infiltrating the drug supply with "knock-offs" that appear to be identical to legitimate drugs. To counter this growing epidemic, pharmaceutical companies and federal and state regulatory agencies are increasingly trending toward requirements for drug "ePedigrees."

An electronic pedigree (ePedigree) is an ever-growing chain of custody detailing a drug's path through the supply chain, in which each company involved in the manufacture or distribution of the drug adds to the pedigree. The seller identifies the drugs and the full chain of custody, then certifies the pedigrees and transmits them in advance to the trading partner receiving the drugs, who authenticates the pedigrees. When a drug shipment arrives, the pedigrees are matched to the products and signed, verifying their accuracy. ePedigree software maintains the product-to-pedigree match while the products are in inventory.

Because pharmaceutical companies must be able to provide the pedigree for any product they produce in the event that drug is "selected" by an inspector, the ePedigree solution performs the critical tasks of (1) managing the pedigree documents of record in a compliant repository and (2) enabling rapid retrieval of the corresponding pedigree. Electronic pedigree self-authenticate automatically, incorporating digital certificates and signatures, with workers immediately alerted to any discrepancies.