Device Checks - 11​.10 (h)

21 CFR Part 11:

“(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.”

Operator station

The valid operator stations that can be used to interact with AVEVA Batch Management are configured in the AVEVA Batch Management Security editor for each role or/and user. A Check box allows accessing all stations declared in the system but it is possible to restrict a user or role to zero or more operator stations for more security.

If the AVEVA Batch Management client is executed on a terminal server, the terminal server needs to be properly configured (not just using remote desktop) so that the client host name can be displayed. Otherwise, the Terminal Server will be the only computer listed in this box as displayed in Figure 31.

Please refer to “Working with Operator Station Security” of the AVEVA Batch Management User’s Guide for more information.

Figure 31 - Operator station access

Usage of other interfaces to log data changes.

AVEVA Batch Management will store parameter changes that are made through the Batch Display interface, along with the user who signed as the “Done By” or ”Check By” user, as part of the Batch record.

If other methods are used to allow parameter changes such as Aveva System Platform Applications Objects, then the information is not logged as part of the Batch Historian record. It is the responsibility of the FDA audited industry to put procedures in place to limit and control the access to other methods for parameter change during batch execution. If such methods are used, they shall require signature and proper historization of the values (for example, in the AVEVA Historian and A2ALMDB).

Input devices

AVEVA Batch Management is usually connected to control systems through ArchestrA objects and DA servers. The verification of the quality of the data coming from these devices is discussed in 21_CFR_Part11_Deployment_Guide.pdf.