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The Oracle Pedigree and Serialization Manager (OPSM) is now available from Oracle (Redwood Shores, CA), some 10 months after the company announced its intention to develop the product. The company says that OPSM is an “integrated mass-serialization and pedigree application” that “generates, stores, transmits and authenticates drug product serial data and ePedigree data.” Integrated analytics allow for improving efficiencies in distribution processes, returns, chargeback reconciliation and related transactional use cases.
“This is a standalone, out-of-the-box solution,” says Arvindh Balakrishnan, VP, Oracle life sciences business unit. “It has built-in business-intelligence capabilities to automate threat analysis, or to manage returns processes and reconciliation.”
Company product literature describes the OPSM as making use of the service-oriented architecture of Oracle Fusion Middleware, which acts as a connectivity solution for moving data from OPSM to ERP systems or other enterprise IT systems, and compatible with Web services, which provide means for transmitting data over the Web.
Andy Binsley, a senior director in Oracle’s manufacturing and asset life-cycle management product strategy group, notes that the company worked with a focus group of manufacturers, including one of the Big Three wholesalers, in designing the product, and that “we are monitoring standards-development processes in the GS1 organization closely” to ensure compatibility as those standards evolve.
Oracle’s offering enters a item-level serialization space not well defined by IT competitors. Companies like Systech (Cranbury, NJ) provide IT solutions to generate and transmit serial numbers; SAP and IBM have applications that store serial data; Axway (Phoenix, AZ) and rfXcel (San Ramon, CA) have solutions that both collect serial data and generate drug-pedigree documents. The GS1 organization continues to work on standards for these applications, while the pharma industry pays closer attention to the 2015 deadline for e-pedigree implementation in the State of California.