Virtual Plant for a Continuous Direct Compression Process– License Package Update Service for Process Automation Software, Engineering Software, and Virtual Controller Software

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA), specifically the Office of Pharmaceutical Quality and Research (OPQR), is conducting market research to identify potential contractors for license maintenance service updates for process automation software and SIMATIC SIPAT (Siemens PAT) software. This initiative aims to support the FDA's mission in ensuring the safety and efficacy of pharmaceutical manufacturing processes through advanced software solutions. Work Details The contractor will provide license maintenance service updates for process automation software and SIMATIC SIPAT software, specifically for a Pharmaceutical Manufacturing Virtual Plant utilizing SIMATIC SIMIT, SIMATIC SIPAT, and PCS7 or equivalent systems. The services required include: 1. Digital Twin: Software Update Service for Process Automation Software; 2. SIPAT: SIMATIC SIPAT Concurrent Method Support; 3. ProcessCare – Plus: PA Process Care Contract - Plus; 4. ProcessCare – Plus System Extension; 5. Field Service Hours: A block of hours totaling 44 hours including travel and on-site time; 6. Field Service Travel and Living Expenses. Period of Performance The contract will have a One-Year Base period from September 30, 2026, to September 29, 2027, with four additional option years extending through September 29, 2029. Bidder Requirements Bidders must be small business manufacturers or capable of providing services as a small business manufacturer or producer. The solicitation is set aside for Small Business Set Aside - Total (SBA). Additionally, bidders should demonstrate relevant experience in providing similar software maintenance services.