Hello good people of the world! This covers qualification of Rockwell Automation’s Change Management software application FactoryTalk AssetCentre. AssetCentre is a application the can be used to implement version control on GxP process PLC, HMI, SCADA, BMS, BAS, etc. software files.
AssetCentre may be considered GAMP category 3: non-configurable off-the-shelf software if you’re using the default configuration, or GAMP category 4: configurable off-the-shelf software if you’re doing some configuration related to your specific processes. There is no customization available in AssetCentre.
Some things that may be configured (and therefore in the scope of qualification) include:
- Database Limitations: the maximum database size, warnings levels, maximum number of versions per asset, etc. may be configured to ensure application performance
- Disaster and Recovery Schedules: the frequency and number of backups of a specific asset or group may be configured
- Searches: searches may be configured and specific unique security rights
- Security Groups: typically security is integrated with the site Active Directory, but additional groups may be configured to apply specific feature security (see below)
- Feature Security: security rights for each feature (e.g. ability to view specific folders, edit the Asset tree, etc.) may be configured
- Database Backups: regular backups of the SQL Server database may be configured
Data integrity issues:
- There is a function (called “Log Cleanup Wizard”) which effectively allows the audit trail entries older than the current day’s date to be purged from the system.
What details do you include in your AssetCentre qualification?
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