Compliance Settings

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.

To configure compliance settings for an organization, see Configure Compliance Settings for an Organization. For more information about each setting see Audit Trail Settings and Change Reason Settings.

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NOTE

The Audit Trail feature is activated for each organization by default. Requiring a Change Reason for Audit Trail changes is an optional setting that requires a GxP license through TetraScience, and isn't activated by default.

Audit Trail Settings

As an organization administrator, you can choose whether or not to track and log user actions for an organization into an Audit Trail. The Audit Trail setting is enabled by default for all organizations when they're created.

For instructions on how to access and review your organization's Audit Trail, see Audit Trail.

To deactivate or reactivate the Audit Trail feature for an organization, see Configure Compliance Settings for an Organization.

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IMPORTANT

You should deactivate the Audit Trail for development environments only. If you deactivate the Audit Trail for production environments, you may not be able to satisfy GxP quality guidelines and regulations.

Change Reason Settings

For customers with a GxP license through TetraScience, organization administrators can choose to require users to enter a reason for changes to an organization's Audit Trail in the TDP user interface. The Change Reason setting provides evidence of how the TDP is being used for a process governed by Good Laboratory Practice (GLP) guidelines in the organization's Audit Trail.

To activate or deactivate Change Reason settings for an organization, see Configure Compliance Settings for an Organization.

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NOTE

The Change Reason setting is deactivated by default and requires an additional GxP license through TetraScience.

Actions That Require a Change Reason

The following table shows the TDP entity and potential user actions that require a change reason when done through the TDP user interface when Change Reason settings are activated:

After a user selects Save or Submit when running one of these actions with the Change Reason setting activated, the following dialog displays, asking them to enter the reason for the change (action):

The change reason the user enters is then added to the log entry that is generated by any of the viewable, searchable, and exportable changes, and displays as an entry in the Audit Trail.