Vault Foundations Hub

Learn how reporting can aid in the ongoing monitoring of system adoption.

If you are new to taking on the role of either Business Owner or IT/System Owner, this quick reference card is intended to help guide you on the assets available to you and suggested timings for activities.

We’ll cover the key roles and responsibilities involved with system ownership, as well as the process for identifying, assessing, planning, and deploying changes on the system.

This session will cover the validation methodology at Veeva (IQ/OQ) and the validation documentation provided by Veeva. We’ll also discuss ongoing change controls and cover some best practices for implementing changes in various environments.

Learn more about our best practices for managing Vault releases. We’ll discuss general releases, maintenance releases, auto-on and configurable features, strategies for preparing for new releases, and change controls for adopting new features.

Veeva offers 3 types of training: Train-the-Trainer, End User Training, and Vault Admin Training. Learn about each of these and how each of these types of training will help and impact your organization.

Learn the basics of document types, workflows, version control, and security. We’ll also cover document creation, metadata, and how to monitor and track progress with dashboards and reports.

Understand the key capabilities of submission content plans, the types of data and documents they track, and each stage of their full lifecycle, from creation to archiving.

Learn how to track any interactions with Health Authorities in Vault using health authority questions, commitments, and correspondence.

Learn how to leverage Vault’s reports and dashboards capabilities to ensure visibility into the work being managed in your Vault RIM.

Learn how Active Dossier functionality can help you maintain a list of current documents for a given product and market in Vault Submissions.

Learn about different options for monitoring the authoring process with custom views and reports.

Learn about suggested naming conventions and regulatory data collection considerations.

Learn how the standard QMS Cycle Time functionality can help your organization report on the efficiency of processes.

Learn how enhancements to QMS now support the ability to collaborate with external parties on audit findings.

This video developed by NNIT focuses on the end-user experience for Learners in Vault Training. A quick reference card is available upon request through askcsm@veeva.com.

This video developed by NNIT focuses on the end-user experience for Managers in Vault Training. A quick reference card is available upon request through askcsm@veeva.com.

This video developed by NNIT focuses on the end-user experience for Training Administrators in Vault Training. A quick reference card is available upon request through askcsm@veeva.com.

Learn how Vault Training can support On the Job Trainings and document the outcomes

Learn about the enhanced periodic review process and how this can automate periodic review tasks.

Learn more about the Process Navigator functionality in Vault QualityDocs, which provides an intuitive interface to assist users in finding information and documents that support a process.

Learn more about how forms that are traditionally managed on paper can be managed compliantly and electronically in Vault QualityDocs.

Learn about controlled document management processes in Vault QualityDocs, including creation, authoring, and review of documents, as well as how the release of changes is governed by Document Change Controls.

Learn about the standard process for processing documents in the Initial to Final Lifecycle.

Learn about the standard process for processing documents in the Draft to Approved Lifecycle.

Learn how to leverage Vault’s reports and dashboards capabilities to ensure visibility into the work being managed in your Vault Quality.

Learn how Clinical-specific email processors can ease the creation of relevant correspondence as well as TMF documents.

Learn how the archival process in Vault eTMF complies with regulations and how to perform a study archival.

Learn about the most efficient ways to create and upload documents to Vault eTMF.

See the recommended QC processes and workflows for Vault eTMF.

Learn how EDL and Milestone functionality is used to help ensure ongoing TMF completeness.

Know what’s required, what’s completed, and what’s missing in your eTMF at all times.

Learn how a CRA plans and confirms a monitoring visit in Vault CTMS.

Learn how a CRA can complete all details of their trip report directly in Vault CTMS.

Learn how the trip report review process is performed in Vault CTMS.

Learn how final approval and documentation is generated for monitoring visits in Vault CTMS.

Learn the basics of creating Inbox Items to initiate the Safety Case processing workflow.

Learn how to leverage Vault's reports and dashboards capabilities to ensure visibility into the work being managed in your Vault Safety.

Learn the process for case intake, creation and promotion.