SmarTeam approached BVJ with the following problem:
Their customer, St. Jude Medical, purchased a SmarTeam PDM System, with the intent of adding enhancements to the system so that the resulting system would conform to their understanding of the FDA regulation publication 21CFR11 (Part 11).
The scope of the development is to enhance the PDM functionality based on the FDA regulations. The main areas that require enhancements are:
The administrator will be able to see the Audit Trail information in a tool similar to the NT Event Viewer. The tool should include the sequenced Audit Trail records, based on the recording time stamp. The administrator should be able to sort by date, user or object class.
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