Request for Information Only - Quality Management Information System (QMiS) Solution

Background
The Food and Drug Administration (FDA) consists of nine Centers and Offices and is an agency within the Department of Health and Human Services (HHS). The mission of the FDA is to promote and protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological and tobacco products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. Amongst other regulatory activities, ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products, and reviews imported products offered for entry into the United States.

Work Details
The draft SOW seeks a complete, secure, robust, configurable, and extensible COTS software suite that provides quality management functions with essential components including documents, quality event management, training, audit, reporting, portal, and integration capability.
It also requires full-service operations, maintenance, support of the solution such as help desk support, planning, troubleshooting, analyses, defect management, release management, configuration management, documentation, testing.
The Contractor shall resolve all issues and defects without delay/dependence on any party not accountable on this contract.