AsAudit
AsAudit ensures integrated support of users’ authorizations and control of performed operations. AsAudit module realizes the following functions:
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Handling the database of users and their authorizations, common for all asix system modules. Except authorizations available in asix v. 4, AsAudit enables protection of access to any file included in application (that means, among other things, it is possible to block for the user the right of command calling, in effect, the right to display specified process screens) and protection of control operations related to individual process variables. All user log-in operations and also all events of attempted unauthorized access to application elements are registered in a database.
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Application file integrity control. This functionality consists in verification whether the contents of the vars database and the application files have been changed in an unauthorized way (i.e. whether user-made modifications were not confirmed through registration in AsAudit database). Each event of files modification is logged in the database.
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Logging control operations performed on selected process variables. AsAudit registers the following data: time of control execution, name of machine performing the control, ID of the logged-in user, value of process variable before the control operation and the control value.
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Logging the operator’s actions. It is possible to register which masks (screens) , tables of variables, trends were opened and closed by operator on the selected asix system stations.
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System of entering and registering the user notes (it replaces the Notepad module available in asix v. 4).
Functionality of AsAudit module in the field of application integrity control and registration of system operation history enables to realize system validation in accordance with FDA 21 CFR Part 11 / GAMP4 regulations, applied in pharmaceutical and food processing industry.
Functions in the range of support of users and their authorizations as well as registration of user’s notes are available in each engineering station, operator station, operator server and terminal license of asix system at no additional charge.
To use the functions of integrity control, logging the control operations and logging the operator’s actions, the additional AsAudit or AsAudit – Lite license need to be bought for the mentioned above asix system licenses. Type of required AsAudit license depends on the basic asix system license used as follows:
WDUW local engineering station – no additional AsAudit license is needed
WDUN network engineering station – AsAudit – Lite license is needed
WATW, WAEW, WALW, WABW operator station– AsAudit – Lite license is needed
WACW, WAAW, WAUW operator station – AsAudit license is needed
Operator server – AsAudit license is needed
Terminal – AsAudit – Lite license is needed