Most Warehouse Management Systems (WMS) available on the market today do a fine job of allowing their users to manage inventories in the warehouses of drug manufacturers, distributors and chain drug stores. A WMS is a software system that may be a part of a larger Enterprise Resource Planning (ERP) system, or it may be a third-party application that is interfaced with the owner’s ERP system.
All WMS systems that I am aware of are intended to be sold into multiple industries, not just in pharma. That’s so that the WMS vendor can maximize their sales. The more industries, the more sales and the more profitable it is. Because some industries have long had serial numbers on some of their products (computers and peripheral equipment, cell phones, electronics, medical equipment, appliances, etc.) WMS vendors have included serial number handling in their software for decades. In fact, I would bet that a serial number handling feature was included in WMS systems since the very beginning of that category of software.
However, buyers of WMS systems in the pharma supply chain should be very careful not to confuse a “serial number handling” or even “serialization” checkbox on the WMS vendor’s spec sheets with the kind of “serialization” they will need for compliance with modern pharma serialization regulations. I include the California Pedigree Law, the potential future serialization requirements that may (or may not) be coming from the FDA, and those in the E.U.
THE DIFFERENCE BETWEEN WMS SERIAL NUMBER HANDLING AND PHARMA SERIALIZATION FOR REGULATORY COMPLIANCE
The reason is simple. Despite the similar (or same) name, serialization in the pharma supply chain leads to significantly different functionality than dealing with serial numbers on products in other supply chains. For example, think about what would be needed for a personal computer manufacturer. They would need to keep track of which serial number is applied to which models. They may want to keep track of who they shipped which serial number to, and they may want to connect their warranty registration, returns, warranty claims and service processes to their serial number database so they can make sure they know exactly which sub-model revision (hardware, firmware and software) they are dealing with and to confirm that the customer is valid (for after-sales service). All of these serial number tasks can be easily accomplished within the WMS, within an add-on module, or within some module of the ERP system because they normally do not need to communicate with the systems of other companies. These same kind of capabilities would be needed for all of the types of products I listed above.
But these capabilities are distinctly different from those that members of the pharma supply chain are going to need going forward and so these traditional serial number features of WMS systems are insufficient. The pharma supply chain needs to use the serial numbers on drug packages to authenticate the supply chain history, either at each stop (California), at the point of dispense (E.U.), or somewhere in between (potential future U.S. FDA regulation). This requires a different approach.
First, all companies within a given supply chain must follow certain standards to ensure interoperability of the serial numbers themselves and the how they will be handled across all members. That is, a WMS vendor can’t simply make up their own serial number handling features because they will not interoperate with those from other vendors. Second, some kind of standardized data exchange related to the serial numbers must occur between trading partners, and third, the management of the data must also be standardized so that the same functionality is made available to all parties in the supply chain.
STANDARDS ENABLE INTEROPERABILITY ACROSS THE SUPPLY CHAIN
In the U.S. and in many other countries around the world, GS1’s Global Trade Item Number (GTIN) plus serial number (or SGTIN) is the standardized serial number that has been chosen (see my essays “FDA Aligns with GS1 SGTIN For SNDC” and “California Enforcement Subcommittee Moves To Require FDA SNI” and also see the GS1 General Specifications).
In California the GS1 Drug Pedigree Messaging Standard (DPMS) is known to be usable for compliance and would fulfill the necessary standard format for data exchange and data management. However, the industry has more recently been interested in the use of GS1’s Electronic Product Code Information Services (EPCIS) standard as the basis for the standardized data exchange and data management. Personally I don’t think anyone has shown satisfactorily that it will comply with the current California law but it appears that companies who are members of GS1 U.S. Healthcare Traceability group are hoping that it will. (See my essays “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2”.) If the California Board of Pharmacy is willing to accept it, then it can be used for compliance, but until we know that, I think it’s risky to deploy systems that are only based on EPCIS.
We won’t know which standard will fulfill the needs of whatever federal pedigree regulation, if any, may be on the horizon until the regulation is published by the FDA down the road. So far it is probably a good bet that EPCIS will play an important role and it is very unlikely that DPMS will play any role. We’ll see…
Ignoring the debate over which GS1 standard would be used in the U.S., the point is, the existing serial number handling features of today’s WMSs will not be sufficient because they are intended for something else. The key characteristic that both DPMS and EPCIS have that is missing from those existing WMS features is that they are able to document supply chain events that occur to GS1 serial numbers and therefore to the products associated with those serial numbers. This includes Commissioning, Aggregation, Shipping and Receiving, among others. When you include the fact that they are both standards that all solution developers can follow, which results in interoperability between their solutions, DPMS and EPCIS are the only ways to address the needs of these modern requirements in the pharma supply chain.
WMS AND SERIALIZED EVENT REPOSITORIES
I once thought that WMS and Pharmacy Management System (PMS) vendors would see the difference and perhaps would add at least the standard EPCIS interfaces to their products (see my essay “The Future of Traceability Repositories and Inventory Management Systems”), but as far as I know that hasn’t happened. Perhaps they have concluded that a WMS isn’t really the place to store supply chain events.
The whole point of a WMS is for managing inventory and warehouse processes. Serialized supply chain events are related to things that pass through the inventories, but the life of those events could extend well beyond the life of the typical data element a WMS needs to deal with today. The data communications and management needs of serialized supply chain events is also beyond the traditional scope of a WMS. It now seems to make more sense to have a separate repository just for those events and maintain minimal connection between that repository and the WMS. Perhaps the only connection would be related to the time that the serialized products are present in the inventory that the WMS is managing.
That might require some interface(s) between the two systems since the serialized event repository is an inventory system of a sort. For each product code the WMS will likely maintain an inventory count and the event repository will likely maintain a list of serial numbers in the same inventory.
If you are shopping for a new WMS and you know you will need to comply with a pharma serialization regulation, make sure you fully understand the limits of the serial number handling capability of the products from each vendor you are considering. Don’t assume that you will be covered just because the spec sheet has a check box for “serialization”.
2 thoughts on “The Serial Number Handling In Your WMS Probably Isn’t Sufficient For Pharma Serialization”
Thanks for another insightful blog posting. In general, I would agree that most WMS systems have this shortcoming of not being able to commission a standard serial number, communicate it in a globally acceptable standard way and store the info, if required, for e-pedigree queries but when you combine WMS in with a strong ERP offering then it is possible to comply with the “current” Pharma requirements…
E.g. SAP integrates the SAP Object Event Repository and SAP Auto-ID Infrastructure, which are 2 separate SAP modules, with their WMS offering. SAP OER will provision an enterprise-wide sGTIN to be consumed by SAP AII which would trigger packing, loading and shipping events using barcode / RFID readers. These events are then sent to the OER which is an EPCIS compliant repository of events allowing for the secure querying of the “pedigree” of the product while it moves through the enterprise supply chain.
So, within SAP, it caters for its own pedigree needs. What the industry falls short, and legislation requires, is the emergence of centralized “OER” services out there where SAP OER could publish their pedigree data too… Although the OER could be exposed to external querying through secure web services. …
Good points Dirk. This complexity area should not be overlooked regarding level of detail and analysis needed to EPC pharma serialize the warehouse processes including upstream and downstream transactions. Additionally, the separation of serialization data from matl/batch/qty inventory mgmt needs to be well understood as well.
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