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    Home > Biochemistry News > Biotechnology News > New Gatorᵀᴹ Part 11 software helps you easily comply with FDA regulations

    New Gatorᵀᴹ Part 11 software helps you easily comply with FDA regulations

    • Last Update: 2022-08-30
    • Source: Internet
    • Author: User
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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


    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

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