Over the last quarter century major shifts in records storage, multimedia management, disclosure requirements, electronic product submission, scientific computing and federally mandated records keeping requirements make it necessary for FDA to move from a paper centric agency to a media neutral information-based organization. This contract will provide direct support to FDA’s move to a broader information-based organization by supporting core functions related to the processing records material that support scientific advancement, public health issues and the regulatory review process. All FDA Offices and Centers are stakeholders under this Indefinite Delivery Indefinite Quantity (IDIQ) Vehicle.
The scope of this contract entails operation, management, and support of FDA onsite document, records and information management related activities. Support encompasses records lifecycle activities, quality control, DCC management, storage services, onsite DCC scanning, training, metadata management, and records management.
Records include regulatory, administrative, and program materials that support the agency’s business functions. Business functions of the FDA pertain to human and animal pharmaceutical and biological drugs, scientific research, food safety, medical devices, and public health issues.
