Trading partners across the pharmaceutical supply chain are preparing for the FDA’s final enforcement deadline for DSCSA. However, many are struggling with the complex challenge of forming DSCSA interoperable connections.
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.”
The data (Transaction Information and Transaction Statement, abbreviated as TI and TS) needs to include a Product Identifier. The identifier captures a package’s serial number and expiration date, enabling serialized tracking per package. This is a change from exchanging data at the lot level, usually done electronically via Advance Shipping Notice (ASN). Most companies have now adopted GS1’s Electronic Product Code Information Services (EPCIS) standard, and have either updated or are in the process of updating their systems to process these files.
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.
One goal that LSPedia pursued in 2022 was to find a way to speed up DSCSA interoperable connections. Since these can take great amounts of 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. 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.
There’s only 10 months left to DSCSA’s enforcement deadline — and considering the complexity of the task, that’s not much time. If you haven’t yet begun to prepare your data management resources and coordinate with your trading partners, it’s a good idea to get started early in 2023 and place a high priority on creating DSCSA interoperable connections.
For more information, contact us or write to DSCSA@lspedia.com.