As we close in on the deadline for compliance with the Drug Supply Chain Security Act (DSCSA), many organizations find that their pharma serialization providers are not up to snuff. When DSCSA was enacted over ten years ago, many pharmaceutical manufacturers raced to adopt serialization and track and trace solutions to ensure efficient product traceability, better monitor their supply chains, reduce product diversion, improve patient safety, and ensure DSCSA compliance. However, some partnerships have yet to be as fruitful as anticipated due to underperformance by their serialization providers, so a DSCSA assessment is needed.
Here are four crucial areas to assess your serialization provider to determine if you have the right partner for efficient DSCSA compliance.
Scalability for Future Expansion
A scalable solution is essential in the innovative pharmaceutical industry. Pharma companies are often on the cusp of a significant drug release and are targeting expansion. Therefore, a serialization partner that can sustain growth is an important aspect to consider.
You need to be able to add components and change the configuration as you grow and move forward. Can you leverage growth and expand production with your current solution? Scalability goes hand in hand with performance.
Often with serialization, adding new product SKUs in production may be cumbersome. Your serialization solution should be flexible and allow you to seamlessly add and manage new SKUs without drastically modifying current workflows. Additionally, your service provider should understand your current systems requirements and be able to anticipate your future needs as you grow.
Seamless Integration with Off-The-Shelf Hardware
A serialization vendor that uses nonproprietary equipment is preferable. This eliminates the need to purchase specific equipment for the project and allows you to utilize existing systems. Plus, integration is always easier with non-proprietary equipment. Seek out a provider that uses off-the-shelf equipment that is nonproprietary to the vendor.
The best approach is to use industry-standard interfaces. Look for a system that interfaces with industry-accepted printers and verifiers without proprietary hardware.
Also, easy integration with ERP systems is a necessity. Seek out a system designed to integrate into existing or future ERP systems easily. Furthermore, getting up and running quickly is desirable. Ensure your system is designed to be up and running within hours and provides all the components required for serialization operations in a compact and easy-to-use system.
Competitive Pricing
When evaluating price, it is essential to ensure that the total cost is aligned with your company’s budget. Check that all costs are included in your serialization contract. Establish if you will be billed separately for services such as support. As the market and technology mature, costs traditionally tend to decrease. This trend has also been true in the pharmaceutical serialization space.
Serialization service costs are generally broken down into two categories: Implementation fees (usually billed as a one-time, flat rate to install and deploy the solution) and Subscription fees (ongoing recurring costs to maintain your service). Implementation fees tend to be higher than recurring costs – although this may not always be the case. When assessing a solution provider, one should consider the overall costs for implementation, maintenance, and separate fees that may accrue (e.g., connecting new trading partners, adding additional SKUs, after-hour support, etc.). Contract length and flexibility to terminate an agreement should also be taken into consideration.
Exceptional Service and Support
Customer support is one of the most critical aspects of client retention and satisfaction. With DCSA’s complex serialization requirements and mandated deadlines, high-quality support is a must. Without excellent support from your vendor, the project will be strained.
It is common to hear about unsatisfactory customer experiences in DSCSA implementations. Companies have been reporting that their serialization providers are up charging them for support service and that premium support is only given to vendor’s large customers, leaving small companies with less than exceptional support.
Other complaints about vendors are constant changes in project management personnel, lengthy wait periods to receive responses for support requests, and increasingly elongated ETAs to resolve technical issues. Carefully consider whether your service provider can support your requests in due time. It is essential to assess if your serialization provider can cater to your requests and manage your support tickets without delay.
Partnerships are a vital component of the pharmaceutical ecosystem. Promptly connecting to new partners is necessary for drug tracking and tracing. Delays in these connections can impact compliance and medicine distribution. When partners are using the same serialization partners, the connections should be prioritized and connected in a timely manner. Ensure that your provider can effectively manage those connections.
