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, Vault 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 the following standard objects and their object types: Adverse Event Report, Batch, CAPA Action, CAPA-Quality Event, Change Action, Change Control, Change Plan, Complaint, Complaint-Batch, Continuous Improvement, Deviation, Deviation-Batch, Finding, Impact Assessment, Investigation, Issue Escalation, Lab Investigation, Lab Investigation-Batch, Material, MedTech CAPA, MedTech Complaint Details, Mitigation Action, Nonconformance, Product, Quality Event-Batch, Quality Event, Quality Incident, Root Cause, SCAR, SCN Impact Assessment, and Supplier Change Notification. These are collectively referred to as the “supported object” in this article.
Providing a Reason for Change
If you update one or more fields on a supported object record, 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:
- In the dialog, select a Reason for Change from the drop-down. For example, Input Error.
- Provide a Comment if the selected reason requires one. Otherwise, use the Comment field to optionally provide additional justification.
- Click Save.
Upon saving, Vault captures the reason for the change, the affected fields, the user who made the change, and when the change was made. If the Reason for Change section is available on the supported object record’s details page, and you have the appropriate permissions, you can view the logged reason in this section. Once created, Reason for Change records are not editable.
Related Permissions
You must have a security profile with the following permissions to work with Reasons for Change:
| Type | Permission Label | Controls |
|---|---|---|
| Security Profile | Object: Reason for Change | Ability to view Reason for Change records. |
| Security Profile | Object: [Supported Object]: Object Control Permissions: Reason for Change | Ability to view the Reason for Change application control. |