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John DiPalo
Chief Strategy Officer
Acsis Inc.

Supply Chain Comment

John DiPalo is Chief Strategy Officer at Acsis Inc., a leading provider of lightweight, cost-effective solutions that fill visibility gaps in supply chain execution. He has more than 25 years of process and systems analysis and design experience. Prior to joining Acsis in 1998, John was an SAP Integration team lead at Deloitte Consulting, as well as the director of SAP consulting for both IMI Systems and IntelliCorp Corporation.

November 3, 2016

Drug Supply Chain Security Act: Is Your Warehouse Ready for Item-Level Serialization?

The Right Solution Will Increase the Efficiency of Your Distribution Operations


DiPalo Says...

The solution you choose today to manage serialized data in your distribution process will have an operational impact for years to come.

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As 2017 quickly approaches, pharmaceutical companies are gearing up for the next phase of compliance with the Drug Supply Chain Security Act (DSCSA). This phase, due to be implemented by November of 2017, will require that manufactures serialize all product with a unique serialized identifier at the saleable unit level. Unlike the 2015 deadlines, for which companies were required to share batch-level data electronically or by updating shipping documentation, this next phase will have a significant impact on the operational aspects of moving product through the pharmaceutical supply chain.

What’s the big difference about item-level serialization? Each item must be treated as a unique, serialized entity that can be tracked individually. This condition is necessary to meet not only the 2017 deadlines, but also many of the requirements that you can see on the timeline between 2017 and 2023 (for the ultimate goal of full, unit-level traceability).

In general, many companies have met or are in the process of meeting the 2017 unit-level serialization requirement at the packaging lines within their own facilities. However, the challenges arise in the readiness of contract manufacturing organizations (CMOs) and the ability to handle serialized product in distribution centers in an efficient manner.

With the focus now turning from applying serial numbers to pharmaceutical product during the packaging process to managing serialized data within the supply chain, companies should take a good look at their distribution processes to determine and plan for the impact that serialization will have on operational efficiency within the warehouse. The serialization and traceability choices that companies make in the warehouse will directly affect their ability not only to ensure compliance with the DSCSA, but also to minimize the long-term cost of managing serialized product within their supply chain.

Most ERP or warehouse management (WM) solutions were not built to manage and track product below the batch level, but this level of granular management is required in the serialized world. In order to solve this problem, many companies are looking at “edge” solutions to capture the receipt, movement and shipment of serialized product and update ERP and WM systems, as well as serialization repositories or EPCIS systems.  

When evaluating an edge solution, there are a number of attributes companies need to think about:

  • Can the solution handle both serialized and non-serialized product using the same transaction set?

  • Is the solution modular, allowing you to implement the components required for short-term compliance requirements, and add additional functionality over time?

  • Can the system be quickly extended to cover additional use cases and transactions?

  • Has the solution been engineered to handle the transaction volume that serialization creates in a distribution center? Rapid response time is the key to operational efficiency.

  • Can the solution capture serialization data even if your wide area network is not available?

The solution you choose today to manage serialized data in your distribution process will have an operational impact for years to come. Naturally, the priority is compliance with the DSCSA, but the right solution will also increase the efficiency of your distribution operations. Streamlined serialization, data collection and management – from the production line through distribution – provide a foundation for tighter returns and recall processes. And with those process improvements, you can ultimately realize an ROI on your serialization investment.

The Acsis team will be at the sold-out HDA Traceability Seminar November 9th through 11th in Washington, DC, and we will be demoing our edge solution as well as our serialized shipping station. If you are attending the show, please contact us at sales@acsisinc.com or call us at 856-673-3000 to schedule a demo, or stop by our booth and we can review your serialization needs. If you are unable to make the event, contact us in order to schedule a demo of our solutions at your convenience.

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