We hear this story often: Your longtime technology provider said they'd roll out a complete DSCSA solution next month...back in July 2022. A little later, these solutions were "in the works" or "in final testing" or "at final phase with our partners" or even "getting vetted by our top guys." However, at no point was it actually introduced for your company, and you still don't have evidence that it works, that it's complete, or that it exists.
Six weeks ago, the pharmaceutical industry had its clock set for the final phase of DSCSA. Rather than giving lagging solution providers more time, the FDA's announcement of the stabilization period for DSCSA emphasized that all the groundwork for compliance needed to get done ASAP. After November 27, 2023, everyone is expected to move from implementation to working out the kinks in their systems, and those who reverse course or slow down are placing themselves and their trading partners at risk of regulatory action.
This should have lit a fire under all those providers who had been playing for time. When the FDA says it'll have an eye out for those who aren't making real progress toward compliance, it's time to show results. If you're working with a provider who hasn't, it's time to switch.
It's important to consider that each connection can take weeks. DSCSA processes require adaptation time; it's unrealistic to expect to simply flip a switch on November 27 and be done with it. Then, there are seasonal challenges: summer vacation time, fourth-quarter earnings, and annual contract cycles, on top of running a business. That's why so many trading partners are realizing that no deal or package their supplier offered can outweigh the risks of noncompliance — which include the risk of not being able to receive or sell pharmaceutical products at all.
When you hire a provider for something as essential as regulatory compliance, you have every right to expect evidence of results. Evidence that they can process EPCIS files; evidence that persistent technical issues will be fixed; evidence that they can, indeed, transact the data that the law requires for every product exchange. Anyone who says otherwise is asking you to take an absolutely unreasonable risk, given what's at stake.
And, frankly, they should be doing more; compliance is the ground floor. As our VP of Services, Rose Campasano, advises:
"If you have a serialization partner, put the pressure on them. You now have key metrics in that system, you can see your inventory and shipments ... Push on them to get value beyond reports."
There's another reason so many companies are looking to change providers: The very construction of DSCSA, across its requirements for interoperable data exchange, serialization, and authorization, means that any uncertainty around a business can seriously impact its partners. That's why some pharma trading partners have set their own deadlines, complete with penalties, for suppliers to be compliant far in advance.
Being a DSCSA compliance provider is a heavy responsibility, carrying the need to guarantee that all requirements will be met, all connections will be formed and monitored, all problems will be found, and all customers can rest assured that their business is protected. At LSPedia, we believe that we're not just providing you with a package of solutions, but a proven track record that you and your partners can trust.
By the same token, a pharma business that relies on a lagging DSCSA provider runs a critical risk of prioritizing that faulty, frustrating relationship over those with trading partners — and patients.
If your provider is unresponsive and failing to deliver, ask what they can conceivably do to resolve your concerns in time for stabilization. When your business and reputation are on the line, ask for proof.
LSPedia is ready to help immediately, bringing any new customer into compliance far in advance of the DSCSA deadline. We can move fast thanks to OneScan's cloud-based and system-agnostic serialization solutions; our Investigator exceptions management technology automatically finds EPCIS errors and quickly guides each fix; and our work has the benefit of numerous trusted industry partnerships.
Our reputation is built on delivering results: supply chain continuity, consistency, and optimization. You shouldn't expect — or accept — anything less.
Get in touch today to switch to LSPedia.