Reporting and Tracking Spontaneous Adverse Experience Reports via a Computer Database

  title={Reporting and Tracking Spontaneous Adverse Experience Reports via a Computer Database},
  author={Linda S. Hostelley},
  journal={Therapeutic Innovation \& Regulatory Science},
  pages={171 - 177}
  • L. S. Hostelley
  • Published 1 April 1989
  • Computer Science
  • Therapeutic Innovation & Regulatory Science
Creation of a computerized document tracking system utilizing a FOCUS software package provides the user with a means of verifying the receipt and transmission of safety information within and outside of the immediate product safety department. In addition, this computerized document tracking system, coupled with a spontaneous adverse experience database system, provides management with the capability of monitoring adverse experience information and its processing. 

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Evaluation of Drug Adverse Event Intake and Reporting in a Medical Information Service

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Multiple Suspect Drug Report Product A Manufacturer Date File Product control sent to Receipt number Section code number the FDA date 870099 1 Β

  • 1985