Vault SubmissionsArchive

Securely access your complete history of regulatory submissions.

Vault SubmissionsArchive is an authoritative source for submissions that enables faster, more accurate interactions with health authorities around the world.

Advanced search and dynamic filters help you find the right document fast. Navigate PDF links within the viewer for a complete picture of an application’s lifecycle.

BENEFITS
  • The right content to the right people: Dynamic access control based on business rules makes it easy to administer document security.
  • Faster responses to health authorities:Easily locate historic submissions including those submitted by regional offices or local affiliates.
  • A global, authoritative source: Allow remote team members to access authorized submissions from anywhere in the world.

Advanced search and filters help locate the right submission quickly

Navigate across the lifecycle for a given document

See and link to other submissions containing the same document

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
An integrated, cloud-based viewer for eCTD, NeeS, and legacy submission formats 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 or downloading files.
FULL LIFECYCLE VIEWING
View the complete dossier lifecycle with current, sequential, and regulatory action views. View cumulative changes for each document. Learn about Vault Registrations
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.
VAULT RIM DATA MODEL
A single regulatory data model enables the Vault RIM applications to contribute and share information so data flows seamlessly between regulatory tasks.

Demos & Videos