Chances are you’ve had a lot of conversations with potential technology partners about their serialization and traceability platforms. Regardless of which software supplier you ultimately choose, there are some common strategies you’ll want to follow when it comes to deploying any new serialization solution to ensure compliance with regulatory requirements, including the U.S. Drug Supply Chain and Security Act (DSCSA) and the European Falsified Medicines Directive (FMD). Without a strategy in place, you could overlook critical elements for compliance and cost your business valuable resources.
When meeting with potential serialization partners, make sure to discuss their deployment process to determine the level of support you’ll receive and the roles your company, your supply chain partners and other technology suppliers will need to play. Keep in mind that while processes will differ, there are three deployment phases that form the backbone of an effective rollout.
Understanding each deployment phase can help ensure that you’re doing your due diligence – whether you have chosen a partner and now need to meet compliance dates, or you’re still evaluating options.
PHASE 1: PROJECT INITIATION
The first phase of a successful deployment is to create a project implementation plan and timeline. This helps you accurately map out your project work stream and scope, and identify the necessary documentation and framework to fit your business needs. As you create an implementation plan, conduct a formal audit of all the IT systems, data and hardware that live within your enterprise, and understand your trading partner capabilities that exist within your supply chain. Consider that you’ll want to easily connect to them to gather, as well as share streams of serialization data.
The transmission of serialized data is very different than the transmission of a lot-level document when communicating downstream events to your trading partners. Lot-level documents can be electronically communicated via a service like email. However, to meet item-level serialization requirements, all solution providers need to directly connect to each of your trading partners or allow distributors a secure web portal login for the receipt of that data.
Ask your technology providers: do they still need to make a connection on your behalf to send serialized data to your trading partners (or have a portal that allows them to retrieve the data)? Look for a serialization software provider that will manage and validate each of those connections for you. Avoid providers that offer poor onboarding and do not assist you with the validation phase or the management of the connections to those downstream trading partners.
In addition, make sure you think globally during this phase. The reality is that supply chains cross borders and oceans during a product’s journey from the manufacturer to its final destination. Understanding and defining the scope of implementation up front can better prepare your company and serialization partner as they work to build schedules, identify partners and create your implementation plan.
For example, during the project initiation phase, one large company we worked with took a step back and redefined its user requirements according to the company’s strategic business needs. The project manager made sure that the requirements were measurable, could be converted into functional specifications, and those functional specifications can be eventually validated against. This minimized complications during later the stages of deployment.
PHASE 2: CONFIGURATION AND VALIDATION
Now that you’ve scoped out your situation, developed an implementation plan, and audited your partners, systems and data requirements, you are ready to begin the configuration and validation phase of serialization deployment.
This is perhaps the most important phase of the project. During this phase, all the due diligence completed in the project initiation phase will pay off as your serialization partner begins to build a solution that matches the needs of your business. Keep in mind that architecting a solution that aligns with your needs doesn’t need to be expensive or time-consuming. It just means that your serialization partner is matching the system functions to your business requirements.
As you work to determine validation requirements at the corporate and product/packaging levels, think about how you can create the most efficient process for requesting and reviewing performance and compliance validation data. An integral component of this phase is to understand the data standards that will support connectivity with each of your partner networks. For example, data exchange standards like GS1’s EPCIS standards provide pharma brands with a common language for sharing information among supply chain partners.
With a common data language that is widely used and supported, you can be confident that your serialization platform can sift through the mountains of data. In turn, this data will provide actionable insights to better drive your business forward and achieve end-to-end visibility.
In addition to leveraging the necessary data standards, make sure you discuss connection and platform requirements based on the partner/network audit results that you completed during phase one. For example, a multi-tenant architecture where all customers share the same instance of the platform, may prevent you from making software updates that work best given your resources and timelines. On the other hand, a single-tenant architecture where each customer gets a dedicated instance of the platform and code base, gives you the ability to update the system when you want based on your specifications – not the software providers. Whether you are working with CMOs/CPOs or third-party logistics providers (3PLs), understanding the platform architecture as well as your network partner readiness can be critical if you hope to deploy quickly and gain meaningful insights in the long run.
During this second phase, continuing a consultative dialogue with your technology partner is also key to allow for the right connections and configurations or determine if new functions must be included. For example, not every solution includes real-time reporting and advanced analytics that give direct insight into your supply chain operations. These insights are vital for extending serialization value beyond compliance.
PHASE 3: GO-LIVE SOLUTION HANDOFF
After approving the platform and checking connectivity requirements, the sign-off stage will begin the final testing of the platform and connections between your supply chain partners. Once final testing is complete, you’re ready to initiate the final validation and training steps.
Hands-on training for anyone in your organization and partner networks that will be working with the serialization system is important – and often overlooked. The right training should be more than just an overview and should include system setup, validation, reporting and testing. While a good serialization partner will make itself available for further training down the road, having your team understand the entire system at the outset will pay off in the long run. This leads to more than just a surface change – it creates a cultural change within the company that ingrains the idea of using serialization to improve business outcomes.
As you start to use your new system on a day-to-day basis, there will be opportunities to refine the data collection and analysis, as well as determine the most optimal reports for various roles and partners. Work with your serialization software partner to determine how value-added reports can be generated at this phase, so you can have them available when needed.
As changes or updates to the platform are made, your connections may also need to be re-validated to meet compliance requirements. While you should run validation tests, you also need to find out how the supporting system architecture could be impacted. Costs and disruptions can be reduced if you proactively work with your partner to accurately test, train and prepare for changes.
VALUE IS IN THE DETAILS
In the end, successful serialization deployment depends on an open and transparent partnership between you and your technology providers. Preparing and gathering the right information at the beginning, understanding the true needs of your own company and your partner network companies, and immersing employees in training early all help improve success.
Despite what some vendors will tell you, serialization is not something you “set and forget.” In fact, serialization will be a part of your daily business going forward. Once you have a system in place that meets compliance requirements, you will continue to refine the serialization system to gain even better and deeper insights into business practices, such as optimizing inventory levels, gauging partner performance and understanding supply chain details (e.g., dwell times). While serialization is mandatory, it is also a great investment. By embracing serialization and deploying it properly, any business can reap operational and financial benefits.