Manage the Regulatory
Dossier Lifecycle

Access a complete history of regulatory submissions.


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Veeva Vault Submissions Archive

Vault Submissions Archive provides dynamic search, filtering, and navigation across dossiers and correspondence for fast, accurate interactions with health authorities.

Benefits

Dynamic Access Control

Share the right content with the right people based on configured business rules.

Faster Responses

Easily locate regulatory dossiers including those sent by regional offices or local affiliates to health authorities.

Global Readiness

Allow remote team members to access authorized submissions from anywhere in the world.

Unified RIM

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

Features

eCTD and Non-eCTD Import

Import final submission packages for your records and future reference. Extract and normalize data from the XML to ensure greater accuracy.

Integrated Viewer

Leverage an integrated, cloud-based viewer for eCTD, NeeS, and legacy submission formats, which reduces the number of tools on the regulatory desktop.

PDF Link Navigation

Navigate PDF hyperlinks across documents within a submission, across submissions, and even across applications. There’s no need for separate tools, file shares, or downloading files.

Full Lifecycle Viewing

View the complete dossier lifecycle with current, sequential, and regulatory action views. See cumulative changes for each document.

Dashboards and Reports

Easy, self-serve reporting shows historic submissions by any combination of attributes including: product, application, region, manufacturer, and more.

Dynamic Access Control

Use rule-based security policies to dynamically calculate permissions that ensure people can access what they need and nothing else.

Advanced Data Model

A single regulatory data model enables the Vault RIM applications to contribute and share information so data flows seamlessly between regulatory tasks.

Health Authority Correspondence

Automatically organize and associate health authority correspondence with related submissions to see communications in the appropriate context.

Bulk Submission Export

Quickly export multiple submissions to support product divestitures, collaboration, and outsourced publishing.

Resources for Vault Submissions Archive

Complete History of Archived Dossiers and Correspondence
Product Brief Complete History of Archived Dossiers and Correspondence
Norgine Achieves More Efficient Document Management
Video Norgine Achieves More Efficient Document Management
Best Practices for System-Driven Workflows
Article Best Practices for System-Driven Workflows
Sumitomo Dainippon Pharma Adopts Vault Submissions and Submissions Archive
Press Release Sumitomo Dainippon Pharma Adopts Vault Submissions and Submissions Archive