Animal & Veterinary
JUST THE FACTS
by Jerome J. McDonald, Ph.D.
FDA Veterinarian Newsletter September/October 1998 Volume XIII, No V
FDA’s Office of Regulatory Affairs is engaged in a project to replace several database applications with one application called the Field Accomplishments and Compliance Tracking System, or FACTS. Version 1 of FACTS is now being installed at ORA headquarters and field offices. FACTS is designed to speed communication between ORA headquarters and field offices, and to enable FDA Centers to interact directly with field activities.
FACTS V1 automates a number of operational activities, including issuing and managing sample collection and analysis; sample collection records; sample tracking, accountability, and disposition; reporting of detailed laboratory analytical results for six types of analyses (pesticides colors, elements, mycotoxins, radionuclides, and food additives); reporting analysis summaries for all other sample types; and managing firm (OEI) and registration data. Centers will utilize FACTS V1 to issue sample collection requests to the Field offices, to monitor the completion status of analysis assignments, to enter/update firm and registration data, and to view/retrieve analytical results and other data in the system. FACTS Version 2 will be implemented in FY 1999 and will include inspections, investigations, recall effectiveness checks, compliance actions, and detailed analytical results for all other sample types.
FACTS V1 is currently being installed at CVM. Several of the Center’s personnel have been trained in its use and will be assisting new users in learning how to use FACTS. As soon as functional roles are assigned to CVM personnel, they will begin using FACTS V1 as a major tool to interact with the ORA field offices.