The Establishment Evaluation System (EES)

The Establishment Evaluation System (EES) is an Oracle client/server application, designed to support the Agency's pre-approval inspection program, and replace the current systems (CIRTS, stand alone Paradox, FAX/Phone inquiries and email).

The impact of EES is Agency-wide in that it provides for connections with Field Offices for data transfer and includes improvement in communications, tracking, data transmittal, and trend analysis for inspections. EES is designed to support the pre-approval inspection process and serves: 1. CDER's Office of Review Management; 2. CDER's Office of Pharmaceutical Sciences; 3. CDER's Office of Compliance; and 4. ORA District Offices.

EES provides for: 1. Real-time access to inspection information between the Center, Districts and Laboratories; 2. Access to the status of Applications for the field; and, 3. Reporting, tracking and trending analysis tools.

EES is fully operational within CDER and is operational in the six Region's District Offices and Resident Posts where Pre-Approval Management of Drug Inspections takes place. All sites are currently operational except for Minnesota, Seattle, San Francisco, Nashville, and New Orleans. Completion of rollout of the entire system is expected by the end of FY97.

EES Help File (Can be read with Windows-based operating system)

CDER Home Page | Search | Comment | What's New