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The default Part11 software administrator is responsible for configuring user accounts for users of the Part11 software
During a user session, the GatorOneRS server records all system, software and user events
Figure 1: Part11 client home page
Biopharmaceutical Total Solutions:
Gatorᵀᴹ Part 11 software performs an integrity check every time an experimental method, experimental file or analysis setup is accessed, and alerts the user when unauthorized modifications have occurred
Experimental files created with Gatorᵀᴹ Part 11 software strictly comply with FDA 21 CFR Part 11 regulations
Figure 2.
Gatorᵀᴹ Part11 software records audit trail details including users, activities/events, timestamps
Gatorᵀᴹ Part11 software records audit trail details including users, activities/events, timestamps
Biopharmaceutical Total Solutions:
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