John DiPalo, Acsis, Inc.

The objective of e-pedigree mandates is to track prescription pharmaceuticals across the entire supply chain—from the packaging line to the dispensing pharmacy. With this real-time tracking, we will have a safer supply chain with fewer counterfeit drugs, less diversion and more accurate supply chain data to protect the public. The mandate consists of three major requirements, which are phased in between January 2015 and January 2017. Starting with manufacturers serializing 50% of their products by the first date, the process will end with 100% of products in retail pharmacies in California being trackable back to the manufacturer.

		Inevitably, some manufacturers will take a last-minute “quick fix” approach as the deadlines near. But the better course of action to ensure long-term compliance, is to take the time to identify and understand the operational and system changes needed to implement serialization across the entire enterprise. More specifically, they must examine how the capture, tracking and leveraging of serialization data specifically impacts the various processes in order management, manufacturing, quality management, accounting and especially distribution. By not taking this comprehensive, enterprise view of serialization, many pharmaceutical manufacturers and distributors will end up installing a serialization solution that can only apply serial numbers and nothing more. They will never achieve true, long-term compliance and their technology and process improvement investments will never produce an acceptable ROI.

Enterprise Serialization Data is different

		Mandates like California’s represent a golden opportunity to mine and collect additional data that is related to the product serialized. Manufacturers and distributors should use the serialization process to simultaneously capture key data on the product, the manufacturing process and the customer order itself, which the entire enterprise can use and leverage to improve decisionmaking and operational efficiencies.

		The cost of capturing this additional product data? With the correct systems in place, absolutely nothing. It’s already available to the system because the data already exists within other parts of a manufacturer’s or distributor’s ERP. Combining standard serialization data, which typically includes a National Drug Code (NDC) number, batch and expiration date, with manufacturer-defined product attributes like manufacturer ship date, ship-to location, storage location and more—is called Enterprise Serialization Data (ESD). By collecting and leveraging ESD, the enterprise becomes better informed, which can lead to improved decisionmaking in sales, brand management, QA, distribution, order management and more.

		User-defined product attributes are also known as ‘flexible content data.’ The type or amount of flexible content data is almost unlimited and completely driven by specific needs, such as:

			Unit price sold for—critical for ensuring accurate returns and chargeback

			Customer (next stop in the supply chain)

			Quality Control data—unit weight, catch weight, unit count/quantity, cap torque

		By simultaneously capturing both unit-level serialization data and flexible content data, the manufacturer generates one complete, holistic, high-quality, uniform data set that enables the ERP’s manufacturing execution system (MES), quality control, distribution, order management, business intelligence and accounting modules to access and leverage this data in their own functional areas to improve decisionmaking and drive business value. Capturing and collecting ESD occurs via the serialization management solution so there’s no need to modify ERP, which can be extremely costly, highly disruptive and time consuming.

		Think of it this way: if your DC supports a pick-and-pack operation, it will need to aggregate and de-aggregate product. Instead of making costly modifications to the ERP’s warehousing module to support these activities, you can leverage the ESD set for capturing and merging data at each packaging level. Then your warehouse can augment the ESD set with updated shipping data that is also 100% accurate. In turn, the ERP’s order management and accounting modules will leverage this newly augmented data set to close out the order and issue accurate invoices.

		Another example is capturing data needed by Quality Management. If data such as date of manufacture, manufacturing temperature and amount scrapped is collected at the point of serialization then the QA team has a better, more robust, more comprehensive data set with which to make more timely and well-informed decisions around the management of suppliers, raw materials inventory and manufacturing processes.

		Yet another example is that this highly granular data set can also be accessed and leveraged by the enterprise’s track-and-trace solution to identify the real-time location of any single unit in the supply chain.

What about the other participants in the supply chain?

		The same processes that manufactures implement to provide a holistic view of the serialized supply chain are applicable to the wholesalers as well. Wholesalers need to look at engineering their receiving, pick, pack and ship processes to support the serialized supply chain as well as look to areas for process improvement by leveraging the serialized data to support better metrics, providing customers with the perfect order and adding additional context data to the serialized product to support future business needs.

		When approached correctly, mandates like California’s can yield very positive ROIs and increased operational efficiencies. To get the most of these mandates, the key is to take a ‘big picture’ approach and realize these mandates don’t have to be just a burden. Instead, they can be an opportunity to improve productivity and efficiency across the enterprise. With serialization requirements, pharmaceutical manufacturers and distributors have a golden opportunity to simultaneously collect and mine a pre-existing, yet also powerful data set—Enterprise Serialization Data&mdash;that they can easily define, change and expand to meet their specific needs. By collecting and leveraging enterprise data, the enterprise becomes better informed, which can lead to improved decisionmaking in sales, brand management, QA, distribution, order management and more.

John DiPalo is the chief operating officer for Acsis, Inc., where he focuses primarily on the design and development of Acsis’ next generation products. Prior to joining Acsis in 1998, Mr. DiPalo was with Deloitte Consulting as a team lead for their SAP Integration product group as well as the director of SAP consulting for both IMI Systems and IntelliCorp Corporation. He is also a frequent speaker at industry events on the subjects of shop floor automation, serialization, RFID and barcode technology, and has authored multiple white papers on serialization and supply chain optimization.

Articles

Real business value arises from going beyond simple regulatory compliance for California's e-pedigree mandate