03 Jan Important Serialization Questions and Concerns for Pharma Companies
With the clock ticking down on regulatory timelines, pharmaceutical manufacturers and their business partners must objectively assess their readiness. Waiting is no longer an option. At the same time, recklessly rushing forward and simply “getting it done” may do more harm than good. Yes, time is of the essence, but you and your organization need to take the time to evaluate the systems, partners, and technologies that will get you to compliance.
SERIALIZATION POINTS TO CONSIDER AND QUESTIONS
1. What have you done to make implementation simpler?
Our Answer: We have more than a decade of experience enabling serialized workflows in live production. Each implementation has taught our people invaluable lessons about how to make the process simpler for our clients, including step-by-step instructions and responsiveness starting on Day One and continuing every day thereafter. Easier implementation also includes easier quality validation. The Verify Brand® Software can handle your IQ and OQ for you; we supply stock templates for the process, and if it’s easier for you, we’ll work from yours. Finally, we make integration with your supply chain trading partners simpler by using the global GS1 standard for the messages known as EPCIS. With EPICS and our Global Trading Partner module, adding trading partners is a snap. (A related question to ask propsective vendors: Can we talk to your clients about your implementation service? Our clients are happy to provide glowing references!)
2. Why is your system easier to use?
Our Answer: We believe the best way to answer this is to let us show you how you can get the most relevant data right at your fingertips in simple, easy-to-use dashboards. More than a decade of improving our cloud-based platform based on real-world client needs has made our solution intuitive and user friendly. One important feature that simplifies our offering: we don’t force updates on our clients. You add them when you want — not when we want. Another less obvious feature is flexibility. One serialization vendor is pushing a one-size-fits-all solution using their proprietary messages. At every turn, it’s their way or the highway, which in their view is easier. Our response is, “Easier for whom?”
3. Is there value beyond compliance?
Our Answer: We know that lots of pharma companies are focused on the easiest way to get to DSCSA and FMD compliance. We get that. We would also like to point out that lots of companies became our clients when there were no regulatory requirements because our cloud platform created good value for them. Our customizable reports are quick and easy to generate, so their data can actually provide insights that make their businesses run better. We’d love to share how our clients are creating value out of serialized workflows on everything from return goods control to customer engagement.
4. How big is your network and how easy is it to connect to others?
Our Answer: We’re part of the largest network of supply chain trading partners–including all the major wholesalers–in the pharma industry. This network was created by the international standards body known as GS1 and is based on the message format known as EPCIS. Of course, in addition to the tens of thousands of companies participating in this standards-based network, our existing network includes thousands of connections (in 120 countries and 18 languages). That said, don’t be fooled by marketing messages touting huge numbers of connections. Focus on use of standards and avoid vendors that claim “they are the network” and all you need do is “plug in.” We’re flexible when it comes to file formats and communication methods, and we can quickly and easily add trading partners with our user-friendly Global Trading Partner module, which supports both global standard messages and proprietary message formats. To help you better understand why the Verify Brand Software uses the many-to-many model, which can handle any type of messaging format, watch our video that explains the two different ways serialization providers are exchanging serialized messages with each other.
5. What is the total cost of ownership (TCO)?
Our Answer: When it comes to TCO, be wary of empty promises because unfortunately, the total cost is more than what you were quoted. Some vendors charge extra for translating industry standard formats like EPCIS into their proprietary message. If you’re thinking about an on-premise solution, don’t forget to include the hidden costs for hardware infrastructure, IT personnel, maintenance, and storage costs. We’ve written an entire blog post about how you can avoid the pitfalls of hidden costs, as well as how our solution can save you money throughout your business operations, giving you the best long-term TCO with DSCSA and FMD compliance. The bottom line is this: don’t invest in any platform without a long-term strategy, from implementation to compliance—and beyond. The lowest TCO comes from a cloud platform that’s mature and proven in real-world serialized workflows already in production.
Think about future ROI. Think about using standards and easily integrating with any supply chain partner you choose, not just the ones plugged into your serialization vendor’s solution. Think about a team that supports you 24/7, no matter what. Then contact us.