The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics, and products that emit radiation. The Office of Criminal Investigations (OCI) was established in FDA to identify and prosecute violators who import counterfeit, misbranded and/or adulterated FDA-regulated products that threaten the health and safety of the American public. OCI investigates all criminal violations of Federal Food, Drug, and Cosmetic Act (FFDCA), the Federal Anti-Tampering Act (FATA), and other statutes including applicable Title 18 violations. OCI investigations are currently managed using a legacy Oracle forms based system that has reached its end of life. The system provides very basic and limited capabilities to perform data analysis. The system is not user friendly for collecting data and requires users to duplicate data input on various forms within the system.
The special agents, technical, and administrative staff rely heavily on the investigative management system for daily operational needs to support criminal investigations. Scope IT’s investigative case management system includes two major modules: Investigative module, and Administrative module.
The Investigative module allows users to create a new Referral and Case Initiation Report (CIR). After a CIR is approved for work it becomes a case and you can track Subject History, Report of Investigations (ROI), Memorandum of Interview (MOI), Collateral Request/Response, Inventory of Evidence, Evidence Tracking, Request for Field Property Services, Judicial Action Form (JAF), Asset Forfeiture, and Electronic Surveillance Request.
The Administrative module allows for Property Management, Managing Staff, Managing Passports, and Training Requests.
- Electronically capture all legal documents associated with criminal case records minimizing the paperwork burden for individuals to enable compliance with the Paperwork Reduction Act of 1995
- Functionality to create, view, share, extract, perform dynamic searches of structured and unstructured data across multiple document types
- Default dashboard with the ability to customize individual dashboards to view data, cases, and tasks
- Ability to create and manage e-mail alert notifications
- Workflow capability to perform multi-step approval processes and dynamic routing based on user role and office
- Field level audit trails to facilitate auditable traceability for all actions taken