Documentation Control - 11.10 (k)
- Last UpdatedMar 05, 2025
- 3 minute read
21 CFR Part 11:
“(k) Use of appropriate controls over systems documentation including:
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
(2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.”
A procedural control should be established over the system configuration as there is no automatic versioning of the configuration except for the recipes. This section provides information on the AVEVA tools that can be used to save and later compare some parts of the configuration.The complete AVEVA Batch Management configuration is stored in the ...\InBatch\cfg\config_A folder. Before starting the batch server with a new configuration, it is recommended to save a copy of this directory with a version name. For example Config_A_v1.2_ 2016-01-05. It is also possible to save smaller parts of the configuration individually, as xml, csv or text files for later comparison with third party tools. The following table lists possible exports that may be used to validate that a specific aspect of the configuration did not change since the last saved version.
All of the Environment Display programs allowing a change in the AVEVA Batch Management configuration must be secured using the Security Editor; any access to these programs is then logged in the “AuditEvent” table. A manual procedure must be setup to control that any change to the configuration has been documented after these programs were accessed. Each program listed in Table 3 has the ability to generate a report that can be used to later compare two different versions of the configuration. Note that the only comparison tool included in AVEVA Batch Management is the recipe comparison tool.
Table 3 - Model export tools
|
Configuration data |
Related Program |
Remarks |
|---|---|---|
|
Process model with phases and parameters |
Model Editor
Import/ Export |
To document a configuration change, an xml file of the Unit configuration may be produced
using the AVEVA Batch Management Model Import/Export utility. The Model Editor also has export capabilities but the generated file is a text file rather than an xml file. Using a modified model at runtime requires stopping the batch server and using the Update Runtime command.
|
|
Link db |
Tag linker/ IDE |
The tag linker data can be exported in a csv file using the Export tags menu. Also, the units and phases instances generated in the ArchestrA environment can be saved as csv files using the AVEVA Application Server IDE csv dump feature. Using modified tag linker data at runtime requires stopping the batch server and using the Update Runtime command. Additionally, when interfacing with ArchestrA objects, the modified ArchestrA objects need to be redeployed which is controlled by ArchestrA security. |
|
Security model |
Security model editor |
A report of the security model may be exported as a text file. |
|
Recipes |
Recipe editor |
Approval, versioning and a recipe xml comparison tool are available to identify and control changes to a recipe. We recommend that you enable the "Version at Approval" or "Version at Save" option in EnvEdit System Parameters in conjunction with using the Recipe Compare utility. Enabling one of the versioning options will ensure that all recipe version changes will be archived for comparison. |
|
Trains |
Train Editor |
A report of the train model may be exported as a text file.
|
|
Material |
Material Editor |
A report of the material model may be exported as a text file.
|
|
LogEdit |
Log Editor |
A report of the process logs configuration may be exported as a text file. |
