CORMAC Corporation has been awarded FDA’s Database Support Contract. This contract will provide maintenance and enhancement support for FDA’s Incident/Informant, Tracktor, and Sampling and Testing databases. CORMAC has been supporting Incident/Informant and Tracktor as the prime contractor for the past 5 years and we look forward to continuing this support with the addition of the Sampling and Testing database for the next 3 years.
The Database Support contract includes development and maintenance of tools for capturing and reporting information related to drug manufacturing quality issues:
- Incident/Informant Database – Captures high priority drug quality issues which have a high potential risk to public health and also captures information received from informants reporting possible non-compliance.
- Tracktor Database – Tracks, records, and trends mandatory drug quality defect reporting from Field Alert Reports (FARs) and Biologic Product Deviation Reports (BPDRs). Tracktor also tracks the receipt of District Action Plans (DAPs).
- Sampling and Testing Database – These is a new tool designed to track drug sampling and testing results and provide analytics and analysis of the data.
CORMAC is honored to be selected by FDA/CDER to continue to provide support to these tools that are essential to protecting public health.News