Serialization in a CMO Environment

Recommendations and Next Steps

Whether your company has implemented, initiated or is just beginning to discuss serialization, there are several key recommendations to consider as you move forward.

Develop your own strategy and perspective – Developing a serialization strategy will help to clarify your own business requirements and priorities for a solution. This strategy should consider characteristics of your specific products, their distribution/commercialization environment, regulatory requirements by region, a product security/risk profile, and an assessment of your enterprise business systems (ERP) foundation. Even if your strategy is ultimately to adopt your CMO’s serialization approach, documenting a strategy in this way will arm your team with important information on critical elements and interface points and will highlight the impacts from their strategy or strategies and any gaps that may exist.

Engage early with your CMO – Begin an active dialog with your CMOs to understand their serialization strategy, if they have one, and how far they have progressed in planning, piloting, and implementing serialization capabilities. Conduct a readiness assessment of your CMOs and 3PL partners to determine if and where there may be gaps that you will need to fill. If significant gaps exist, raise the red flags quickly and determine whether the CMO organization is able to support your needs or if a change is required.

Design your serialization architecture – Together with your CMO, develop a serialization architecture for your product(s), including packaging equipment, serial number formats, key information flows, and application requirements. Select widely used industry standards to encode products to ensure future acceptance with major trading partners. Wherever possible, choose configurable solutions and highly-scalable designs to accommodate the high-volumes of serialized data and transactions. Also, create a roadmap of sequenced activities that can be implemented over time, or that will meet regulatory timelines.

Implement opportunistically – Until the technical and regulatory issues are more certain, few organizations are likely to commit significant investment toward broad implementation of a solution. Yet, with extensive implementation timelines and other potential regulatory deadlines approaching, we recommend seizing opportunities to begin implementing the building blocks for serialization. For example, as new packaging lines are constructed or existing lines are retrofit- ted, make sure that any new equipment purchased is serialization-ready. Ensure that packaging components for all new products are designed with space allotted for 2D barcodes or RFID. Prioritize or accelerate elements of your enterprise IT infrastructure that support management of serial number data and data communications, or other aspects of the serialization business architecture.

Conduct a pilot – Work with your CMO to define the scope of a prototype, beginning with a single CMO and product. Once the scope is determined, update the standard operating procedures and related documents, including labeling. Design the cross-enterprise business processes generating serial numbers, and the serial number provisioning model (parent/ child relationships, items to cases to pallets etc.). If possible, to reduce the cost and impact on business operations, leverage existing processes and communication to provide serialization ranges to the contract packager and to receive serialization and serialized container to content information. Define the system for use; who owns the data, how the data are reported, who has access to the data, what errors must be reported, and how they are to be resolved. Then, update procedures and related documents as necessary in preparation for launch of the pilot.