Since 2000, FDA criminal investigations of drug counterfeiting have increased six fold. 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 increasingly require 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 manufacturing or distributing 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.
Pharmaceutical companies must be able to provide the pedigree for any product they produce, in the event that drug is "selected" by an inspector.
- Manage pedigree documents of record in a compliant repository
- Rapidly retrieve the corresponding pedigree
- Automatic self-authentication
- Incorporates digital certificates and signatures
- Workers immediately alerted to discrepancies
Here’s what Ross ERP for Life Sciences can do for you:
Create a Chain of Custody
Detail every drug’s path through the supply chain, including certifications and authentications.
Prepare for Inspection
Ensure you have accurate, signed, and verified product-to-pedigree matches for every product in your inventory