Set Compliance Settings for Your Organizations

To ensure compliance with GxP regulations, the Tetra Data Platform (TDP) provides an Audit Trail for user actions that create, modify, or logically delete electronic records. The Audit Trail can also be configured to require a reason for change.

As an Admin, you can enable or disable the following features:

• Audit Trail
• Change Reason enabled in Audit Trail

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NOTE

Audit Trail is activated for each organization by default. Change Reason enabled in Audit Trail is not activated by default. To set up change reason logging, you must activate it on the Compliance Settings page.

Enable or Disable Compliance Settings

As an Admin, you can enable or disable compliance settings for an organization from the Organization details page.

To enable compliance settings for an organization, do the following:

1. Sign in to the TDP as an admin.
2. In the left navigation pane, select the hamburger menu icon. Then, choose Administration.
3. Choose Organization Settings. The Organization Settings page opens.
4. In the AUDIT TRAIL section, choose Edit. The Edit Audit Trail Settings dialog appears. By default, Audit Trail is set to Enabled and Change Reason enabled in Audit Trail is set to Disabled.

Enable Audit Trail for an Organization

As an Admin, you can enable or disable whether to track and log user actions for an organization into an audit trail. The Audit Trail setting is enabled by default. For instructions on how to access and review your audit trail in the TDP, see Audit Trail.

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Disabling the Audit Trail

You should disable the audit trail for development environments only. If you disable the audit trail for production environments, you may not be able to be satisfy GxP quality guidelines and regulations.

Enable Change Reason for Audit Trail

As an Admin, you can enable or disable the optional Change Reason enabled in Audit Trail setting for an organization. By default, this setting is disabled.

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Toggle Enablement

The Audit Trail compliance setting must be enabled before you can access the Change Reason enabled in Audit Trail setting.

To provide evidence of how the Tetra Data Platform (TDP) is being used for a process governed by GLP guidelines, toggle the setting to enable adding change reasons to the audit trail.

This table shows the TDP entity and potential user actions that would require a change reason when done through the TDP UI as they make changes affecting scientific data for an organization's environment (eligible for change reason and tracking):

For each of theses changes, after you click to save or submit, the following dialog will display asking you to enter and save the reason for the change (action):

The change reason you entered will be added to the log entry that is generated by any of the viewable, searchable, and exportable changes (previously listed in the table), and will display as an entry in the TDP Audit Trail.