New Application Helps Pharmaceutical Organizations Comply with New Regulatory Requirements and Reduce Business Risk.
- Oracle today announced the availability of Oracle Pedigree and Serialization Manager, an integrated mass-serialization and pedigree application designed specifically to improve supply chain integrity in the pharmaceutical industry.
- The new solution helps pharmaceutical manufacturers facilitate compliance with emerging electronic pedigree (ePedigree) initiatives and regulatory requirements, reduce business and reputational risk associated with the rising incidence of drug counterfeiting and product diversion while extending value across the pharmaceutical supply chain.
- Oracle Pedigree and Serialization Manager generates, stores, transmits and authenticates drug product serial data and ePedigree data as pharmaceutical products move across the supply chain. This facilitates counterfeit threat identification and streamlines compliance. In addition, integrated analytics within the solution provide pharmaceutical manufacturers with expanded insight into possible threats.
- Pharmaceutical companies can use this solution to improve the efficiency and accuracy of returns management and reduce associated losses. Non-repudiation capabilities automate assessment and reconciliation of products returned against products shipped, helping to reduce write offs.
- In addition, this software helps pharmaceutical companies maintain stronger channel integrity by enabling them to reduce product diversions, such as from lower reimbursement locations to higher reimbursement locations. It also can help reduce revenue leakage by helping to improve scrutiny of chargeback rebates paid out to wholesalers.
- Built on an open standards-based Service-Oriented Architecture (SOA) and Oracle Fusion Middleware applications, Oracle Pedigree and Serialization Manager is built to integrate seamlessly with existing Oracle and third-party systems for manufacturing, packaging and shipping and receiving.
- Oracle Pedigree and Serialization Manager, which supports Web services and features an intuitive interface, is built with flexibility designed to aid compliance with evolving global regulatory mandates for product mass serialization management.
- Although designed to address the product identification needs of pharmaceutical companies, Oracle Pedigree and Serialization Manager can also be used in any industry dealing in high-value products at risk for counterfeiting and piracy, such as medical devices, high technology or luxury goods.
- “Oracle Pedigree and Serialization Manager is well positioned to quickly capitalize on the present solution gap in the drug pedigree space,” said Eric Newmark, Research Manager, IDC Health Insights. “It delivers all the bells and whistles you’d expect in a serialization and pedigree solution.”
- “Ensuring supply chain integrity is not only about compliance and protecting your brand, it’s also about protecting your bottom line,” said Oracle’s Jon Chorley, vice president SCM Product Strategy. “By definitively identifying your products in the supply chain and providing a broad set of analytic insights on that data, Oracle Pedigree and Serialization Manager will deliver both. The result is a safe and secure pharmaceutical supply chain, combined with a strong ROI.”