The Food and Drug Administration’s (FDA), Center for Tobacco Products (CTP) has authority under the Family Smoking Prevention and Tobacco Control Act (FSPTCA) to regulate the manufacturing, distribution, and marketing of tobacco products to protect the public health. To meet the legislative requirements of the FSPTCA, CTP has an aggressive regulatory timeline and thus wishes to leverage existing FDA processes, Information Technology (IT) systems, and technology where possible, while establishing longer-term IT systems and business processes.

CTP develops information technologies that support specific scientific and business analyses associated with its regulatory and research mission. This is a suite of information technologies collectively referred to as “Advanced Information Retrieval Research System,” or “AIRRS”. AIRRS consists of two software systems – 1) CTP Integrated Information Research System (CIRDS) and 2) Research Tracking System and Workflow (RTS); and it covers three research areas: Ontology, Advanced Text Analytics, and Semaphore.

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The goal is to research, recommend, develop, migrate and implement CIRDS and RTS in four FDA standard application environments, including Development, Test, Pre-Production and Production; and the Operations & Maintenance (O&M) of AIRRS in all four FDA environments.

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To support AIRRS system integration efforts, as part of a team, Cognizance provides development, testing, and operations services.

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Cognizance provides services to develop, configure and deploy CIRDS to all FDA application environments (Development, Test, Pre-Production and Production) following FDA and CTP IT enterprise architecture, processes and FDA IT system security guidelines.

Additionally, we support a range of testing activities covering everything from unit testing to system integration testing to 508 compliance testing to regression testing and performance testing. We also facilitate and assist in conducting User Acceptance Testing (UAT); this includes developing test scenarios/cases for use during UAT, scheduling UAT kickoff sessions, and providing user support during UAT.

Finally, Cognizance provides Operations and Maintenance (O&M) and Support Services.  These services cover Analysis, Monitoring, and Reporting on the impact of the infrastructure, software upgrades, capacity, and all changes to the technical environment.  Primarily we support efforts to monitor and maintain AIRRS availability, by ensuring the appropriate health and operations of the software systems and by taking and coordinating corrective actions when the application(s) is not operational. This includes proactively verifying and reporting application availability and ensuring patching of software for AIRRS is compliant with FDA policies and procedures.