Record Protection 11​.10 (c)

21 CFR Part 11:

“(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.”

Protection of records includes performing scheduled backups of data. Backups must be made and maintained for AVEVA Batch Management databases (BatchHistory and BatchArchive databases) on a regular basis, for example daily full backups and hourly differential backups.

Other backups required in a typical AVEVA Batch Management environment need to be planned; for example, the AVEVA Historian runtime data (history blocks) and the alarms and events database (A2ALMDB) typically contain process data that must be backed up. Please refer to the AVEVA System Platform Deployment Guide, specifically Record Protection—11​.10 (c)for these databases.

Backing up runtime batch data

The batch data is stored in the BatchHistory SQL Server database. The batch data can be backed up, archived and purged using the procedure described in the AVEVA Batch Management User’s Guide under Manage History Files.

Backing up configuration data

The complete and validated AVEVA Batch Management configuration folder (by default: C:\Program Files (x86)\AVEVA\Batch Management\cfg\Config_A) should be copied while the Batch server is shutdown.

It is recommended to save the copied directory with a version name. The content of the version must be documented using a manual procedure. This backup is recommended prior to changes requiring Update Runtime or Update Environment are done from the Environment Display.

During runtime activities, some of the more dynamic configuration databases may be updated with new data (material, trains and recipes for example). Daily backups on the AVEVA Batch Management server are recommended for such changes.

The AVEVA Batch Management configuration data is made of a set of files that can be backed up from the running batch server using the DBCopy utility; the procedure is described on page 742 of the AVEVA Batch Management User’s Guide. A nightly DBCopy backup is suggested to avoid conflicting with possible Update Runtime/Update Environment activities. This may be triggered by by a Windows Scheduled task.

Backing up recipes

The AVEVA Batch Management server can be configured to automatically export new recipes using a B2MML (XML) format when they are changed or approved. A daily backup of these files is recommended since they can later be used to identify changes between versions using the recipe comparison utility.

The system parameter "Version File Path" defines the XML recipe directory path. The system parameters “Version at Save” and “Version at Approval” give the ability to configure the export of an .xml version of the recipe every time the version is saved or approved for production.

These Environment Display system parameters are described in detail in Use the DBCOPY Utility of the AVEVA Batch Management User’s Guide.