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*CDER Informatics Enterprise Service and Operation and WFM New Contract

Forecast

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The CDER Informatics Enterprise Service and Operation and WFM contract provides the Food and Drug Administration with critical enterprise services and operational support for the Informatics system. This project, known as Inbound, focuses on the Panorama Platform, CDERNexus Application, and general platform integration. Key deliverables include a streamlined end-to-end solution for ingesting submission data across various application types, such as ANDA, NDA, BLA, and IND, and the automation of workflow processes within systems like Workfront and Appian based on submission metadata. The contract emphasizes the integration of multiple systems to ensure seamless review processes and strict adherence to FDA record management policies. A significant portion of the scope involves the management, operation, and maintenance of Panorama, a vital review tool used to ensure GDUFA compliance. Additionally, the project supports the Platform Operation Center to monitor production environments and provides ongoing maintenance for document management services to secure industry communications and reduce errors.

General Info

FDA contract for Informatics enterprise services, Panorama platform operations, and submission data automation.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541519 - Other Computer Related Services

Place of Performance

USA

Set-Aside

NONE

Documents

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cder Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.