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Advanced Track and Trace for Pharma could streamline both manufacturing and warehousing data collection and reporting
The enterprise-level resource planning (ERP) and financial management tools of SAP AG are widely used in the life sciences industry, and life sciences in turn is a strategic industry focus of the Walldorf, Germany firm. And while SAP has had a solution set that can address the needs of pharma companies performing traceability or authentication processes in drug distribution, those software tools have been general ones applicable to many industries—implying significant configuration complexity to handle the specific needs of pharma. That will now change with the imminent release of SAP Advanced Track and Trace for Pharma (ATT for Pharma)—a strategic area where SAP has developed an industry-specific solution, according to Stephen Cloughley, SAP solution expert for life sciences.
SAP has a long history in addressing pharma traceability. It was one of the early participants in the MIT Auto-ID lab, which had been developing RFID-based product-tracking in the late 1990s—that led to SAP’s Auto-ID Infrastructure, better known as AII, primarily geared for capturing serialized product identification. Subsequently, SAP developed the Object Event Repository (OER) as an enterprise-level track and trace solution. Bundling the two together gave pharma companies a way to address the data collecting, storing and reporting functions necessary for an enterprise traceability system—and most of SAP’s major pharma customers committed to that solution.
While working with a consortium of customers over the past two years, says Cloughley, SAP made a decision to rebuild the solution, specifically with enhanced reporting resources so that ATT for Pharma can be applied in any national regulatory structure globally. The solution is also built for immediate handling of unit-level serialization (current US regs only require serialization by lot level). Tailored systems for the US, Turkey, China and Argentina will be announced in September; others will be rolled out as various authorities finalize their requirements. “Right now, we’re waiting on final requirements for Brazil, and for the Falsified Medicines Directive in Europe,” he notes.
Another key element of ATT for Pharma is that it applies equally well to warehousing operations, where data volumes can be massively higher, where there is complexity in mixtures of serialized and non-serialized product and where there is a need to break down pallets of deliveries and then (potentially) reassemble them for specific wholesaler customers. (Additional details are described by SAP in sponsored content here.)
A small but growing number of vendors—many of them relatively small IT shops—have been marketing traceability solutions for pharma for the past decade; it’s hard to see at this point which companies will feel the brunt of SAP’s marketing of its new solution. SAP has a history of working with other IT vendors to provide extensions or modifications of its software (but here is where the pharma-only aspect of ATT for Pharma becomes significant). Cloughley says that, between the close collaboration with leading Big Pharma companies, and the fact that it already has several customers lined up, a smooth introduction to the market is expected.