Providing a Reason for Change

Health authorities may require your organization to capture a reason for a change when correcting fields on records associated with certain key processes. If configured by an Admin, QMS may prompt you to provide a Reason for Change if you update one or more fields when an object record is in a particular lifecycle state. Additionally, Vault may prompt you to provide a clarifying comment when you select a particular reason.

For example, if an Internal Audit record is in the In Audit lifecycle state and a user needs to update the Starting Date field, Vault may prompt you to provide a reason for the change and comments before saving the record.

This article provides guidance on how to provide Reasons for Change if prompted, any limitations to using this feature, and related permissions.

Supported Objects

The Reason for Change feature supports a subset of standard objects and all custom objects.

Providing a Reason for Change

If you update one or more fields on an object record or from a record list (for instance, in a custom object tab or related object section), Vault may prompt you to provide a Reason for Change upon saving the record. If at least one of the edited fields is configured to require a reason, Vault displays a dialog to capture a single reason to capture all relevant field changes.

To provide a reason:

  1. In the dialog, select a Reason for Change from the drop-down, for example, Input Error.
  2. Provide a Comment if the selected reason requires one. Otherwise, use the Comment field to optionally provide additional justification.
  3. Click Save.

Upon saving, Vault captures the reason for the change, the affected fields along with their previous and new values, the user who made the change, and when the change was made. If the Reason for Change History section is available on the object record’s details page, and you have the appropriate permissions, you can view and download a PDF of the changes and reasons in this section, or access the associated Reason for Change record to review and print additional metadata related to the specific change. Reason for Change records are not editable.

You must have a security profile with the following permissions to work with Reason for Change:

  • Read permission for the Reason for Change object.
  • Within the Reason for Change object, View permission for the Audit Trail object control.
  • Within the Reason for Change object, View permission for the Reason for Change Source Record object control.

For each object in the permission set that uses the Reason for Change feature, you must have the following permissions:

  • View permission for the Reason for Change History object control.
  • View permission for the Reason for Change object control.
  • View permission for the Reason for Change Capture object control.
  • Edit permission for the Reason for Change Capture field, or the equivalent field for custom objects.