Today, LSPedia CEO Riya Cao joined the HDA Traceability Webinar to discuss the industry’s progress on DSCSA, and the innovations enabling companies across the pharmaceutical supply chain to secure their businesses and trading relationships in the few short months left before the November 27, 2023 enforcement deadline.
During the webinar, Cao raised an interesting point that can help guide conversations on DSCSA: When we talk about getting ready for DSCSA, we're really talking about interoperability, establishing the direct point-to-point connections that enable each pair of trading partners to securely exchange DSCSA data before or at the time of a physical transaction, the requirement at the heart of the new law.
After the November deadline, serialized data will need to accompany prescription drug products every time they change ownership. The law states that trading partners must use a “secure, interoperable, electronic manner” to exchange transaction data “prior to, or at the time of, each transaction.” The data (Transaction Information and Transaction Statement, abbreviated as TI and TS) needs to include a Product Identifier that captures a package’s serial number and expiration date, enabling individual serialized tracking.
This is a change from exchanging data at the lot level via Advance Shipping Notice (ASN). Companies across the industry are now onboarding GS1’s Electronic Product Code Information Services (EPCIS) standard, and are working with their trading partners to create the connections needed to securely exchange them. There's encouraging news in the EPCIS exchanges we're seeing every day: the volume of inbound EPCIS files has doubled in the last six months. However, there's also clear evidence that not everyone's on board yet.
The process is key to successfully implementing DSCSA without interruptions, to the point where some pharmaceutical companies are leveraging their own fines for partners who don't meet internal deadlines (which are often months ahead of the official DSCSA deadline, to ensure that no disruptions occur in November).
To make these data exchanges possible, each business in the pharma supply chain must form a point-to-point connection with each trading partner. These connections exist not only to exchange data securely, but to ensure that any party involved can trace a given single product’s complete history through the supply chain, from manufacturing to the patient-facing dispenser. This is the goal of item-level traceability, ensuring that businesses can find and remove damaged, illegitimate, or dangerous products from the supply chain. From there, they can investigate the issue for related problems that may have wider effects.
This presents a technical challenge for many organizations, particularly those with large numbers of buyers or sellers. Any company in the pharma supply chain will need to be able to access the system of any given trading partner to exchange or confirm transaction data. For example, a company with 50 trading partners will need to support 50 separate point-to-point connections.
Each of these connections can take two to six weeks to complete, and it can take as many as eight more weeks to qualify a connection under the Computer System Validation requirement (from the FDA’s CFR 21 Part 11 compliance). This is an essential element, as misconfigured or incomplete data exchanges can cause delays and other serious impacts.
Effective collaborations on interoperability are essential throughout the supply chain. A single company’s efforts to comply with DSCSA serialization can still be ineffective if its master data can’t be read by a partner. Similarly, an incomplete technical setup can make the exchange too labor-intensive to be easily repeatable. Companies that fall behind on interoperability may find themselves incurring extra costs for labor and problem-solving. Additionally, they risk losing out on the benefits of traceability.
Don't accept excuses. This goes for partners who are lagging -- and providers who aren't making progress for you. In either case, people you're relying on are costing you valuable time. If a partner is not prioritizing EPCIS connections, make clear that they're risking both your livelihoods. (This is why some companies have been penalizing partners who don't comply by their own deadlines, months ahead of DSCSA.) If a provider isn't coming through and wasting your time with excuses, drop them and get real help.
Get a comprehensive DSCSA solution. Don't try to squeak by with incomplete DSCSA tools. You'll want a provider that meets all requirements for your business, including tools for EPCIS, verification, and exceptions management. (OneScan Suite does those and more.) A piecemeal approach to DSCSA can add a lot of manual or duplicative work, and can even obscure important information, adding unnecessary challenges to achieving interoperability with your trading partners.
Use pre-configured connections. Since these connections can take a long time to test and qualify, LSPedia partnered with SAP to offer pre-configured, tested connections. Our teams collaborated on the computer system qualification for AS2 network connections necessary to send DSCSA EPCIS data files. For customers using SAP’s ATTP, the time needed to connect with LSPedia trading partners for EPCIS data exchanges can now be reduced by half or more. LSPedia and SAP also provide compliant qualification documents to support pharma companies’ audit and retention policies. Contact LSPedia to learn more!
Outsource DSCSA. This is now an option! Proactive Resource Group is the top choice for companies in a time crunch or who simply need to focus elsewhere between now and November. PRG will drive the DSCSA process beginning to end, managing all aspects of communication and implementation.