With the upcoming implementation of Veeva Vault 25R1, we’ve been exploring the new features in the QMS Vault and how these will aid your end users.
Quality Event Suggestions
What’s New?
25R1 brings the Quality Event Suggestions feature designed to provide intelligent suggestions for field values on parent and related records, which are generated by analysing the top 100 similar records. Field Suggestions, suggest the most typically referenced values for specific fields in similar records, whereas Related Record Suggestions, suggest the related records that are typically referenced in similar records.

What does this mean for end users?
This feature is designed to enhance efficiency during the triage stage of a Quality Event by streamlining prioritisation and categorisation.
Audit Room Enhancements
What’s New?
In 24R3, Veeva introduced the Audit Room to QMS and 25R1 brings two enhancements to this feature.
This release introduces the Inspector Portal, which has been designed specifically to enable Inspectors to easily view Inspection Records and associated Requests.
25R1 also introduces auto-assignment, where Fulfillers can now be automatically assigned to Inspection Requests.
What does this mean for end users?
The simple navigation of the Inspector Portal allows Inspectors to quickly access essential information, and the introduction of auto-assignment improves the efficiency of the audit response teams.
Reason for Change Updates
What’s New?
Like the Audit Room, 24R3 brought with it the Reason for Change feature. This feature addresses the requirement from Health Authorities to capture why organisations update certain data fields on completed records.
Now, when a user edits a field managed by Reason for Change, a pop-up will appear prompting the user to select a Reason for Change from a pre-defined list and add any required comments.
Once saved the Reason for Change record will include details on what was changed, why and when the changes were made, and who made the changes.
What does this mean for end users?
This feature makes it easier for Health Authorities to audit records, reducing the number of Health Authority Questions received by the organisation.
External Collaboration
What’s New?
25R1 expands the External Collaboration feature, enabling Impact Assessment and Change Action records to be shared with external business partners. Now, once the Impact Assessment or Change Action reaches a particular state, QMS can automatically provide an external user account and send a link to QMS via email to the external user.
Where Tasks need to be reassigned to other external collaborators, this can now be done without the need to cancel workflows. When a new External Collaborator is assigned to a Task, the original Task will be automatically cancelled for the existing collaborator and a new task assigned to the new collaborator.
What does this mean for end users?
The provision of external user accounts streamlines the access for external users by providing them with the minimum required access to specific records, allowing them to perform their task within the quality business process, whilst the automatic cancellation and assignment of Tasks to external collaborators increases operational efficiency.
Root Cause Analysis
What’s New?
Root Cause Analysis records can now be linked to from within an Investigation record, improving ease of use. Previously, users would have to navigate to the parent Quality Event record, to link the Root Causes.
What does this mean for end users?
Now, when a Root Cause analysis is complete, the record is linked to both the Investigation and Quality Event records.
5 Whys Root Cause Analysis
What’s New?
A Save button has been added to the Why box in a 5 Whys Root Cause Analysis. Previously Vault would save changes automatically once the user clicked outside of the Why box.
What does this mean for end users?
This change makes it much clearer to users’ which data they have successfully updated.
What next?
If you’d like any more information about how these features, or any of the 25R1 enhancements will affect your QMS users, please get in touch.





