Vault Submissions

Unite the extended team for easier 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 generation of submission structures to the planning, authoring, and collection of required documents—all in a secure cloud environment.

BENEFITS
  • Global alignment: Maintain greater control over the distribution and tracking of documents that affiliates submit to local authorities.
  • Continuous visibility: Track the progress of documents through actionable reports and dashboards, mitigating risks to submission timelines.
  • Speed to market globally: Eliminate manual processing to speed submission assembly and improve SOP compliance.
  • Stronger: Automate tracking and reporting by authoring, exchanging, and assembling documents directly within Vault Submissions.
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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 eCTD and the DIA EDM Reference Model.
REGIONAL AND MASTER DOSSIERS
Allows users to generate submission structures as part of the planning process. Add planned content, reuse documents globally, and report on content status in real time. See how Ipsen uses Vault to re-engineer their content planning.
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.

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SUBMISSION-READY RENDERING

Automatically renders content in a compliant manner for global regulatory submissions.

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. See how Intercept uses Vault to report on submission status.
APPLICATION INTEGRATION
Provides an open, published Vault API, enabling integrations with complementary Regulatory Information Management (RIM) tools.
REAL-TIME COLLABORATIVE AUTHORING
Seamless integration between Vault and Microsoft Office Online provides real-time collaborative authoring and does so in a compliant way. See a demo.

Demos & Videos