Configuring Reason for Change

Health authorities may require your organization to capture a reason for change when a user corrects fields on records associated with certain key processes. Vault QMS supports the ability for Admins to require users to provide a Reason for Change upon updating one or more fields when the object record is in a particular lifecycle state. Additionally, Admins can require users to provide a clarifying comment when selecting a particular reason. Upon saving, Vault captures the reason for the change, the affected fields, the user who made the change, and when the change was made.

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

This article provides guidance on configuring this in your Vault in addition to limitations to using this feature.

Supported Objects

You can create a Reason for Change configuration for 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.

Configuration Overview

Complete the following configuration steps to use the Reason for Change feature in your Vault:

Add the valid reasons for changing fields to the Reason for Change picklist.
Create Reason for Change configurations for the desired objects and object types.
Update permission sets assigned to users who edit records for the supported object.
Modify the supported object or object type’s page layout to accommodate the Reason for Change feature.
Optional: Add the Reason for Change related object section to the supported object or object type’s page layout. When a user provides a reason for change, Vault creates a Reason for Change record in this section.

Creating Reason for Change Configurations

Complete the following steps in your Vault to create Reason for Change configurations for the desired supported objects and object types.

To create a Reason for Change configuration:

Navigate to Admin > Configuration > Reason for Change Configurations.
Click Create.
Provide a Label, Status, and optional Description.
Select an Object from the drop-down and an Object Type if applicable. The drop-down is limited to standard objects. You are required to select an Object Type if the selected object has two (2) or more object types.
Under the Field Criteria section, select up to 30 standard or custom fields that should require a reason for change. Inactive, formula, and lookup fields are not available for selection. Select which lifecycle states should require a reason for change for the chosen fields. Click the plus (+) icon to add field and lifecycle state combinations or the minus (-) icon to remove field and lifecycle state combinations.
Optional: Under the Picklist Comment Criteria section, select the Reason for Change picklist values that should require the user to provide a free text Comment.
Click Save.

Limitations

The following limitations apply when you create Reasons for Change configurations:

You can define a single Reason for Change configuration for each specific object and object type.
You can only create Reason for Change configurations for standard objects.
The drop-down in the Field Criteria section only displays fields that are editable through the UI and active for the selected object type. If you update a Reason for Change configuration and a selected field has become inactive, Vault clears the field upon saving.
Once a field is included in a Reason for Change configuration, you cannot remove it from an object type.

Updating Permission Sets for Reason for Change Configurations

For each permission set that enables users to edit the supported object or object type in a Reason for Change configuration, assign the View permission for the Reason for Change object. For each supporting object that should be editable from this permission set, assign the View permission for the Reason for Change object control.

Configuring Supported Object Page Layouts

To accommodate the Reason for Change feature, you must add the Reason for Change application control to the supported object or object type’s page layout. This control is not visible to an end user, but it must be in the page layout in order to display the Reason for Change dialog when a user saves a record.

The Reason for Change Capture field exists on every supported object that can use the Reason for Change feature. This field is not intended to be viewed or edited by users, so you should not include it in a supporting object’s page layouts.

You must have a security profile with the following permissions to configure Reasons for Change: