Device History Record Report
Use Device History Record Report (3.6.20; 3.6.44 in the enhanced .NET UI version) to display the production history of a finished device—if it is a serialized end item—or an end lot of finished devices. Multiple levels of component history can be included.
The output of this report can be used by medical device manufacturers to help satisfy the reporting requirements outlined in Food and Drug Administration 21 CFR Part 820, that require the following information:
• The dates of manufacture
• The quantity manufactured
• The quantity released for distribution
• Any device identifications and control numbers used
The report includes the components used, their lot or serial numbers, the date of issue, the ID of the user who performed the issue transaction, and the transaction number. In addition the labor recorded is displayed with the user ID of the user who recorded the labor and the transaction ID.