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FDA Awards CORMAC the Database Support Contract

September 1, 2017

Cormac

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.

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