Veeva Vault Registrations

Vault Registrations provides a global application for planning, tracking, and reporting on product registrations and health authority correspondence and commitments.

Benefits

Improved Data Quality

Streamline registration management by reducing data duplicates and discrepancies.

Global Visibility

Stay informed with complete visibility into the marketing status of your global product portfolio.

Faster Responses to Health Authorities

Track product registration queries and commitments to stay ahead of response deadlines.

Unified RIM

Connect end-to-end regulatory processes and improve efficiency with the Vault RIM Suite.

Features

Global Product Registrations

Manage all marketing and investigational registration information, including packaging specifics, indications, and manufacturing details. Manage updates to registered data and report on latest approved details.

Health Authority Interactions and Commitments

Retain and classify all correspondence with health authorities. Create commitment records with related tasks and report on progress against outstanding commitments and deliverables.

Variation Management

Track proposed changes to global registrations. Determine the impact of a proposed change and delegate actions to local affiliates to execute the change in their market. Optionally, leverage a seamless connection with Veeva Vault QMS to automate the creation of any planned change triggered by your quality change control process.

Submissions Tracking

Plan, manage, and track the status of regulatory submissions and related activities. This includes the data related to initial clinical trial submissions (CTAs, INDs) and initial marketing submissions (NDAs, MAAs).

Product Data Snapshots

Generate XEVMPD data snapshots from your latest registration data, allowing manual overrides, generation of health authority required output, and bi-directional communication via health authority gateways.

XEVMPD and IDMP Support

Accommodate XEVMPD and IDMP source data points in the context of regulatory data management and pull in information from other systems through Vault’s open API.

Dashboards and Reports

Create easy, self-serve reports showing information by any combination of attributes including product, application, region, manufacturer, and more. Address any bottlenecks or delays by re-assigning tasks or sending reminders directly from within the report.

Affiliate Home Page

Encourage local user adoption with a specific user interface that allows market product owners to view all country-specific data points in a simple graphic format with quick-launch buttons to update local data.