Top 3 Reasons to Start Planning Your Serialization Pilots Now
With the first DSCSA serialization deadline just over two years away, pharmaceutical companies are beginning to think about pilot projects. That’s why TraceLink’s upcoming NEXUS ’15 event will dedicate an interactive workshop to the topic, helping companies to identify best practices and connect with potential piloting partners. Workshop chair Mike Ventura – a 30 year veteran of the pharmaceutical industry and former GSK executive – shares his thoughts on why companies must begin planning their pilot projects now.
1 - Only pilots will help you understand how serialization will impact your overall business
You can’t fully understand the complicated scope of serialization until you step into the water. What does it actually take to serialize product and make the necessary adjustments to your business processes?
As a pharmaceutical business, it’s not simply about understanding the regulatory requirements, but addressing details like "How do I get serial numbers into the bar codes on my product? How do I create the necessary white space on my packaging?"
You have to consider the line upgrades, too, and plan for taking lines down for a period of time so upgrades can take place. That means you need to build stock and make sure that you’ve got enough inventory so that you don't disrupt your supply to patients in the process.
Overall, piloting will give you great insight as to what the overall impact of serialization will be to your organization.
2 - Pilots are your opportunity to confirm you have the right serialization solution for the long run
Some companies put a short-term fix in place to meet the DSCSA lot level deadline. With serialization, businesses really need to assess what's scalable and sustainable enough to meet their serialization requirements for years to come. Remember, compliance directly affects a company’s ability to sell; if you're not compliant, you’re out of business. Beyond that, the right serialization solution ultimately adds value to your business and helps protect patients.
Pilot projects are your chance to evaluate if your proposed solution is up to the task. For instance, if your platform relies on point-to-point connections, pilots will allow you to gauge how time-consuming and resource-intensive it is to set up and validate each one. Will the speed-to-deployment your solution offers meet your needs? And will you be able to support the ongoing maintenance?
Your success will be critically dependent on having a robust solution in place. Pilot projects are an opportunity to identify any problems and make the necessary adjustments while you still have time.
3 - Pilots are the first step towards identifying value in serialization beyond compliance
Companies need to invest in serializing product in order to meet the regulations, but if your company doesn’t do anything else with all of the resulting data, it’s ultimately wasting money and resources. There’s a great opportunity here to say, "Once we’ve got products serialized, what intelligence can we leverage from that?"
This journey isn’t only about compliance. It’s about patient safety. It's about reimbursement fraud. It's about the integrity of your brand
All of this is tied together. It's about leveraging the investments that you make
There is a huge white space for ideas around how to best orchestrate pilots, and how to capitalize on the return-on-investment opportunities that serialization ultimately offers.