There's an atmosphere of urgency in the pharma industry. With only four months remaining until DSCSA goes into full enforcement, trading partners that haven't yet moved to comply are looking to take quick action -- and they often find themselves facing the challenge of interoperability.
This requirement can pose a significant challenge. Any pharma company relying on "making time for DSCSA this fall" runs the risk of discovering too late that they haven't properly gauged the scale of work and collaboration needed. While the time constraint may seem daunting, four months can still be plenty of time if companies use them effectively.
After November 27, 2023, serialized data will need to accompany product every time it changes ownership. The law states that trading partners must use a “secure, interoperable, electronic manner” to exchange transaction data. This must happen “prior to, or at the time of, each transaction.” Transaction Information and Transaction Statement data (abbreviated as TI and TS) needs to include a Product Identifier that captures a package’s serial number and expiration date, enabling serialized tracking per package. This necessitates adopting a new standard, from using lot-level data via Advance Shipping Notice (ASN), to product-level data via GS1’s Electronic Product Code Information Services (EPCIS).
Under DSCSA’s interoperability requirements, any individual business in the pharma supply chain must form discrete point-to-point connection with each one of their trading partners, whether it's a buyer or seller relationship. 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.
Start the conversation now and push the timeline. Effective collaboration and communication on interoperability is essential. Your company’s efforts to comply with DSCSA serialization can still be ineffective if your data can’t be received by your trading partners. Similarly, an incomplete technical setup can make the exchange too labor-intensive to be easily repeatable. Companies that fall behind on interoperability may incur extra costs for labor and problem-solving. And if the problem is within your organization, share resources and training!
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, give them resources to learn what they need to do and how to do it, and emphasize that they're risking both your livelihoods. (This is why some companies penalize 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, ditch 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.
Outsource DSCSA entirely. Yes, 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.
For more information, get in touch with our team today!