*CDER Informatics Enterprise Service and Operation and WFM New Contract

The Informatics Enterprise Service Project, commonly referred to as Inbound, provides CDER Informatic system with enterprise services and operation support (Panorama Platform, Panorama O&M, CDERNexus Application O&M, and CDER Informatics Platform Integration). Services include: Streamlined end-to-end solution to ingest submission data for all application types (ANDA, NDA, BLA, IND) from ASR and kicks off accurate workflow processes to the targeted workflow management systems such as Workfront and Appian based on the submission metadata (eCTD backbone + application form). - Launches workflow processes in the context of application/submission review phase, capture review decisions, trigger additional review process based on different decisions, and archive the FDA review documents to FDA's defined record management system. - Expands and improves integrations between systems. This is important to CDER because the review process involves several different systems that need to work in sync of one another. Without the integration services, CDER would not be able to complete their review processes. One service under this project is to expand and maintain services for document management. Proper document management is important because it must adhere to FDA record management policies, secures communication with industry is seamless, and less error prone. - Includes operations and maintenance (O&M) support to all enterprise services that are part of the project. - Covers the complete management, operations, and maintenance support of Panorama. Panorama is the review tool that houses the majority of the OGD, OPQ, OM, and a few other review process workflows. Panorama plays a major role ensuring GDUFA compliance. - Supports the Platform Operation Center (POC) capability to monitor and maintain production environments.