FDA - DCCs

Since 1990, ZAI has operated Document Control Centers (DCCs) for each of the Food and Drug Administration (FDA) Centers, providing comprehensive information management of hardcopy and digital records related to human and veterinary drugs, medical devices, food safety and cosmetics, and tobacco. We manage an estimated 3.5 million active and inactive regulatory records in accordance with NARA regulations and FDA Record Control Schedules. We procses a half million incoming submissions annually, comprising more than 135 submission types, extracting information and performing complex data entry into 32 FDA systems.

ZAI provides records management services for multiple FDA Centers. ZAI develops and maintains Records Control Schedules, conducts records inventories, prepares and updates File Plans, manages physical and electronic record archives, and dispositions records in accordance with FDA and NARA records retention schedulesand processes.