As time dwindles to the FDA's November 27, 2023 deadline for DSCSA enforcement, some pharmaceutical trading partners are still struggling with the complex challenge of forming DSCSA interoperable connections. After the 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, usually done electronically 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.
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).
Under DSCSA’s interoperability requirements, a 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 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.
In 2022, LSPedia sought a way to speed up the process of creating, testing, and qualifying DSCSA interoperable connections, which resulted in our partnership with SAP to offer fully pre-configured connections.
Our teams collaborated on the computer system qualification for AS2 network connections necessary to send DSCSA EPCIS data files. The publication of the Operational Qualification Report last August showed that LSPediA and SAP had deployed reliable infrastructure and connections for a Third Party Integrator.
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.
Considering the complexity of the task, the time left to form these connections may be tight for your organization. If you haven’t yet begun to prepare your data management resources and coordinate with your trading partners, it’s a good idea to start now, guided by experts at DSCSA implementation. Contact LSPedia today, or write to us at DSCSA@lspedia.com.