From manufacturing to point of sale, companies across the pharmaceutical industry are facing a complex challenge in meeting DSCSA’s interoperability requirements. Starting in November 2023, all sellers will need to provide serialized data to buyer partners every time a product changes ownership, using the GS1 EPCIS standard.
Since every company has its own EPCIS data repository, transactions require network connections with each one of your partners. If your business has 50 suppliers, you’ll be forming 50 point-to-point connections. If it has 100 customers, you’ll need to make 100 of these connections.
Each of these connections can take two to six weeks to complete, and it’s not unusual to add eight more weeks to qualify the connection under the Computer System Validation requirement from the FDA for CFR 21 Part 11 compliance. Misconfigured or incomplete data exchanges can cause delays and other serious impacts.
A new partnership with SAP to offer pre-configured, tested connections represents the next step in LSPediA’s evolution. These connections can be a game-changer, given the challenges around DCSCA compliance and the 2023 timeline.
Now, if you’re a customer of SAP, you can onboard LSPediA’s entire network of trading partners with pre-configured connections, without the need to qualify each point-to-point connection. LSPediA SAP Qualified Network Connections make establishing EPCIS data exchanges easier for trading partners in the U.S., especially pharma manufacturers.
To help customers take advantage of our systems, expertise, and 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 on August 2, 2022 showed that LSPediA and SAP had deployed reliable infrastructure and connections for a Third Party Integrator.
“Our customers are challenged by the complexity of DSCSA in an FDA validated environment. Collaborating with SAP to qualify the network connections makes DSCSA implementation a little easier,” said Riya Cao, CEO of LSPediA. “LSPediA’s effort pays forward for the best benefit of our customers and the industry.“
The time requirement for connecting with LSPediA trading partners can now be cut in half or more. Companies using SAP’s ATTP can enjoy streamlined onboarding for EPCIS data exchanges directly with LSPediA. Additionally, compliant qualification documents are provided to support pharma companies’ audit and retention policies.
Onboarding trading partners for interoperability with EPCIS data exchanges is critically important to the 2023 DSCSA compliance deadline. If your company uses SAP ATTP, you’re already halfway there. Click here to start EPCIS onboarding with LSPediA. For everyone else, contact us today.
To learn more about DSCSA compliance, join an upcoming DSCSA training.