LSPediA, a leading provider of enterprise supply chain software in the pharmaceutical industry, announced an easier way for pharmaceutical manufacturers to connect with trading partners, enabling point-to-point EPCIS1 data exchanges. EPCIS is an interoperability requirement by the FDA under the Drug Supply Chain Security Act (DSCSA).
With LSPediA SAP Qualified Network Connections, SAP customers can now utilize pre-configured and tested AS2 network connections when onboarding with trading partners on LSPediA’s network.
Companies across the pharmaceutical industry are facing a significant challenge in meeting DSCSA’s interoperability requirements. Starting in November 2023, sellers at all levels will need to provide serialized data to buyer partners every time a product changes ownership, via the GS1 EPCIS standard. The necessary connections take an average of four to eight weeks to complete, multiplied by the number of trading partners a company has. On top of this, manufacturers who validated their repository under the FDA’s requirement for CFR 21 Part 11 must also validate these network connections, a process that can last as long or longer than the initial setup. With the DSCSA’s deadline just over a year away, demand is skyrocketing for solutions that can rapidly and correctly establish and qualify these connections, saving time, money, and stress.
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To help their customers eliminate the risk of business disruptions, LSPediA and SAP collaborated on the computer system qualification for AS2 network connections for EPCIS data exchange meeting both DSCSA interoperability requirement as well as the CFR 21 Part 11 requirement. An Operational Qualification Report (OQR) published in August 2022 is now available to customers from LSPediA and SAP. Companies can keep the OQR as part of their validation documents and use it to demonstrate the adherence to CFR 21 Part 11.