Sequencing - 11​.10 (f)

21 CFR Part 11:

“(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.”

One of the main feature of AVEVA Batch Management is to execute sequences of phases and transitions as defined in approved recipes. Please refer to AVEVA Batch Management User's Guide: Chapter 8 Recipe Editor - Building a Recipe Procedure for details on building the sequence.

The recipe sequences are enforced by AVEVA Batch Management at execution time. The following features allow the user to operate out of sequence and therefore should be restricted to high level users with at least a “Done By” signature. Figure 11 shows how to set this up in the AVEVA Batch Management Security Editor.

• Phase skip

• Phase jump

• Phase abort

• Batch abort

• Manual Batch execution mode.

Usage of any of these features is recorded as part of the Batch Record.