No matter what industry you're in, being unable to ask for help is a problem. In professional contexts, the notion often spurs the fear that actively seeking assistance will damage one's standing, based on unfounded perceptions that a competent person in that position would already have or would be able to figure out a given problem, or even that such a move would invite interference.
Yet, working in any fast-paced environment means being able to learn and adapt, and to face new situations realistically and with thorough information. And this certainly describes the pharmaceutical supply chain in 2023, the final year of implementation for the Drug Supply Chain Security Act.
If you haven't started at all on implementing DSCSA yet, you really have no time to lose. Since your very ability to do business -- accepting and selling prescription drug products -- is at stake, attempting to bolt a variety of capabilities onto your existing operations at the last minute will be laborious, difficult, and potentially even dangerous. (Particularly when "the last minute" is the start of the 2023 holiday season.) In this case, getting DSCSA help now is crucial.
There's a lot of variation in the industry. Some businesses may be well prepared for DSCSA, and are now in the process of putting the final touches on compliance and collaborating with their trading partners on secure data exchanges. Others may have a hazy plan to decide on a solution mid-2023; there are also those who understand DSCSA well, but have misperceptions regarding how the FDA will handle the final deadline.
No matter where you are in the process, it's important to understand that finding DSCSA help in 2023 doesn't mean discarding any work you've done so far! It's a good idea to select a flexible, system-agnostic solution that gives you the option to keep your ERP system (assuming it's effective and otherwise achieving your goals for it). LSPedia's OneScan Suite offers this kind of scalability, thanks to a modular design that can be adapted to the requirements and challenges of any organization.
However, there's an irreplaceable aspect that many organizations overlook: building your organization's knowledge base.
By now, you probably know the basics for your business: what it means to be an Authorized Trading Partner, using a unique product identifier, accepting EPCIS data, processing verification requests, making appropriate FDA reports, and the like. However, each company’s operations, challenges, pain points, and compliance journey are unique.
You'll need to navigate your organization through the new law on a strategic and operational level. Without a strong base of knowledge to draw from, the new problems that will inevitably crop up this year amid the industry’s transition to DSCSA can be overwhelming.
So, you’ll want to have someone who’s an expert on both DSCSA and your own company -- and soon. The nine months to the enforcement deadline will go fast, particularly when working to ensure that your DSCSA implementation doesn't add any friction to your organization's supply chain operations.
LSPedia's DSCSA classes combine broad background information with interactive tools to ensure that attendees come away with practical firsthand knowledge of EPCIS, VRS, product tracing, exceptions management, 3911 FDA reporting, interoperability, master data, and more.
The sessions also involve insight into structuring an organization’s DSCSA implementation, integrating DSCSA solutions with business systems, and how the process fits into all trading partner operations.
Contact LSPedia to get these on your calendar:
Finally, join our Exceptions Pilot for insights each week regarding the errors that can fully stop product from moving. Our experts, joined by collaborators from across the industry, are tackling some of the toughest problems facing the pharma supply chain.
There are plenty of resources available -- don't wait too long before asking for help with DSCSA! You can drive a complete and smooth implementation and ensure that your business, your trading partners, and patients are fully protected. And if you don't know where to start, book time with an expert! Everyone needs to start somewhere.