24R3 New Features

With the upcoming implementation of Veeva Vault 24R3, we’ve been exploring two significant new features and how these will aid your end users.

Veeva Quality Vault – QMS – Audit Room

The 24R3 release introduces the Audit Room feature to Vault QMS. The Audit Room has been developed to streamline the management of live third-party audits, focusing on speed, accuracy, and collaboration to enhance the efficiency of audit processes. Once the Audit Room has been configured, it can integrate seamlessly with existing Audit and Inspection workflows.

This new feature consists of two main components:

1. The Audit Room

Audit Response teams can access the Audit Room via the Audit record, where requests and responses can be filed and managed. Audit Response teams can manage Audit Room Requests in the same way as Vault records, by routing them through configurable workflows. The Response section of an Audit Room Request record allows users to populate approved fields and allows for Vault Documents and Attachments to be referenced. Only Published, fulfilled responses will be made available to Inspectors, ensuring that quality and accurate responses are provided to all inquiries.

Whilst compiling responses, the Audit Response teams can also make use of Scribe Notes for less formal collaboration, provided Collaborative Authoring is enabled.

2. The Inspector Portal

TThe Inspector Portal allows organisations to invite external parties directly into their QMS Vault. Inspectors with access to the QMS Vault will only be able to access Audits that they have been invited to participate in and will have no access to any other areas of the Vault. Once in an Audit, Inspectors can view the list of Published Audit Room Requests where they can review and close as appropriate.

With all Inquiry and Response data captured in Vault, Reports can be run, and Dashboards can be created enabling teams to understand trends and gain valuable insights.

Veeva Clinical Operations Vault – CTMS – Disclosures

24R3 introduces Vault Disclosures as an optional add-on to Vault CTMS. Vault Disclosures is tailored to each organisation, helping navigate the complex regulatory environment by ensuring data quality and accuracy. Integration with the Vault Clinical Operations suite improves efficiency by eliminating the need for manual submission processes and third-party integrations, by pulling Documents, data and milestones from eTMF, CTMS and Study Startup.

With Vault Disclosures, all Disclosure activities are centralised. Pre-configured Rules ensure regulatory compliance and data and Document reuse accelerates submission timelines, ensuring faster, accurate submissions.

Check out Veeva’s recent video on Vault Disclosures for more information.