Prelude Computer Solutions, Inc.

  Product Safety Update Report (PSUR)

The Periodic Safety Update Report (PSUR) is required as part of the FDA Post Marketing Drug Risk Assessment (PMDRA) program.  The PSUR report is evolving with the ICH initiatives and the February 2004 FDA Guidance for industry.

The PSUR software is designed to track the submission of Periodic Safety Update Reports by marketed product and country.  The PSUR is a practical mechanism for summarizing interval safety data covering short periods of time and for conducting and overall safety evaluation.  It is a tool for marketing authorization holders (MAHs) to conduct systematic analyses of safety data on a regular basis. 

PSUR tracks basic information such as International Birth Date (IBD), Product license number and renewal date, and the date range of the report.  Information on all indications, dosage forms, and regimens for the active substance can also be tracked as well as the affiliate requesting the report. 

This database is designed according to the FDA model for a periodic safety update report as incorporated into your SOP for PSUR reporting. PSUR tracks the initiation date for requests for information and the receipt of that information from the various corporate departments that contribute to the PSUR report.  Besides the dates, provision is made to link the various documents and components to the PSUR tracking records for immediate retrieval of that report component. 

The PSUR cover sheet report is printed with all this basic report information as well as all the tracking information.  The PSUR cover sheet is attached to the PSUR report submitted to the FDA. 

All changes to the PSUR database are captured in an audit file and there is provision for the user to log all significant events to a log file. 

Reports and Customization

Several standard reports on inventory status, distribution and requisition are provided.  We understand that your clinical trial supply requirements may differ from the packaged application and we will work with you to insure that your requirements are met.



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