Record Availability - 11​.10 (b)

21 CFR Part 11:

“(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.”

Viewing Recorded Data

All AVEVA software has been tested to ensure all data stored in the databases is accurate and complete. AVEVA Batch Management provides out of the box reports based on Microsoft SSRS (SQL Server Reporting Services).

The Batch Reports web site is secured and available through the BatchReport Icon in Environment Display as depicted in Figure 8:

Figure 8 - Batch Reports Web Site

The following reports are available:

Viewing Recorded Alarms and Events

Although phase parameters high and low deviation limits may be defined in AVEVA Batch Management and downloaded to the control layer, the AVEVA Batch Management system does not have its own independent alarm management system (unless using AVEVA Batch Management with Foxboro DCS Components). Instead, alarms are stored in the AVEVA Alarm system. Standard ActiveX and .NET controls are available to view both the current alarms and the historical alarms. The alarms related to a given batch are included in the batch report provided that the ArchestrA objects generating the alarm are prefixed with the name of a unit or connection that was allocated to the batch.

Alarms are discussed in more details in the AVEVA System Platform Deployment Guide.