FDA ORA Systems for Inspections, Recalls, Compliance and Enforcement (SIRCE)
Investment ID: 009-000005317
Overview
Program Title
FDA ORA Systems for Inspections, Recalls, Compliance and Enforcement (SIRCE)
Description
SIRCE enables a collection of systems used by ORA staff for Workflow Management, facility inspections, investigative operations, Data Management, Data Sharing, Decision Support, Security and Access Control, consumer complaints, and other critical ORA activities. The investment maintains familiar and essential IT tools that enable ORA to adapt to new requirements from legislation and growing business needs.
Type of Program
Major IT Investments
Multi-Agency Category
Not Applicable
Associated Websites
https://itacs.fda.gov/app/welcomeToITACS.jsf, http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm2006836.htm, https://www.accessdata.fda.gov/scripts/ora/mpqa
Investment Detail
The first benefit for an enhanced SIRCE set of applications is the resulting cost avoidance by the ORA staff being more efficient in executing their tasks. This results in each employee able to carry out more inspections, etc. Examples of this are: 1.Reduced time spent on recall removals and corrections, and enforcement reports. 2. Improvements in executing compliance actions and work activities. 3. Reduced time spent on inspection/investigation administrative tasks with the advent of eNSpect. The cost avoidance of these benefits is estimated to be $2.724M per year. The second benefit to increase the industry/trade participants staff efficiency by $2.361 per year. A third benefit for cost avoidance is based on the value of a human life estimated at $7M. This benefit assumes that to save 5 lives per year in the United States from improved inspections, there must be continually improved systems. An argument could be made that this number should be much higher since just one outbreak of disease or drug reaction could take far more many lives. Qualitatively, SIRCE enables ORA to effectively increase public health and improve workforce productivity. SIRCE benefits the public by enabling risk-based inspections and import screens that ensure medical product safety and the farm-to-table safety of the food supply. SIRCE expanding ability to share data with other public health organizations improves the nation's ability to detect, identify, and respond to health emergencies. SIRCE's internal benefits include improved user interface, data management, and communication systems that increase productivity and enable ORA staff to spend more time on their important public safety duties.