Vault Submissions

Unite the extended team for easier document authoring and submission assembly.

Globalizing processes becomes substantially easier with a single authoritative source for submissions content. With Vault Submissions, you’ll handle everything from the auto-generation of submission content plans to the planning, authoring, and collection of required documents—all in a secure cloud environment.

BENEFITS
  • Continuous visibility: Track the progress of documents through actionable reports and dashboards, mitigating risks to submission timelines.
  • Speed to market globally: Automate multiple tasks to speed submission authoring and assembly.
  • Global alignment: Maintain greater control over the distribution and tracking of documents that affiliates submit to local authorities.
  • Unifying regulatory: Streamline end-to-end submission development, gaining visibility and efficiency with the unified Vault RIM Suite.
View Demo

Deploy Faster with Built-in Support for eCTD and EDM Models

Identify and Remedy Bottlenecks with Interactive Dashboards

Navigate Quickly with Clickable Links in the Document Viewer

Features

EXTENSIBLE CONTENT MODEL
Supports and extends industry best practices for content models like the DIA EDM Reference Model.
SUBMISSION CONTENT PLANS
Auto-generate the table of contents for major submissions. Add planned content and report on submission status in real time. Reuse content plans globally.
ROBUST LIFECYCLE MANAGEMENT
Automates manual processes with workflows and lifecycles. You can even change in-flight workflows with ease.
GLOBAL ACCESS AND COLLABORATION
Eliminates the need to bring external users behind the corporate firewall, issue laptops, or provide network IDs. Authorized users log in via the web to a single, secure, cloud location.
SUBMISSION-READY RENDERING
Automatically renders content in a compliant manner for global regulatory submissions. Learn about Vault Registrations
INTERACTIVE DASHBOARDS

Drill down through interactive dashboards to narrow in on the exact source of delays. Take action directly from the reports to address hold-ups quickly and stay on track for submission deadlines.

TRACK SUBMISSIONS
Plan, manage, and track the status of submissions and related activities.
MANAGE INTERACTIONS AND COMMITMENTS
Retain and classify correspondence with health authorities. Create-and-relate commitment records with associated tasks, and report on progress against outstanding deliverables. Hear how MacroGenics does it.
INLINE EDITING AND DATA ENTRY
Enter information directly in Vault as easily as in Excel. Select from drop down lists, pick calendar dates, and use keyboard shortcuts to enter and update information quickly, as you would in Excel.
SCAN DOCUMENTS ON THE GO
Easily scan documents directly into Vault from an iPhone or iPad. With the snap of a button, documents are encrypted, secured, and automatically uploaded to your Vault. See Veeva Snap in action.

Demos & Videos