Submissions

Regulated Document Management in the Cloud

Veeva Vault Submissions is a modern cloud application for authoring and managing regulatory submissions content. Vault Submissions gives life sciences companies greater access, visibility, and control over their submissions information. Content creators securely access and contribute to documents from any location, at any time, and on any device.

Robust Lifecycle Management

Flexible workflows and lifecycles guide the authoring, reviewing, and approving of submission content. Authorized individuals can easily change in-process flows by adding, removing, or emailing participants. Country specific actions accommodate regional variations in global processes.

While managers track the progress of submission documents through actionable reports and dashboards, mitigating risks to submission timelines. And with a global system, companies establish greater control over documents that affiliates submit to local authorities.

Vault Submissions is part of the Veeva Vault RIM suite of applications. The suite provides fully unified regulatory information management (RIM) capabilities spanning submission document management, submission archiving, health authority correspondence and commitments, and product registration management.

Extensible Content Model

Vault Submissions supports and extends the content models. Create binder templates with pre-configured planned documents and your Microsoft Word® templates to streamline content into defined submission structures. Then auto-populate document names and metadata fields based on binder values to further reduce manual overhead.

Global Access and Collaboration

Vault Submissions combines the ease-of-use of the consumer web with the stringent control required for validated systems. Authorized users log in via the web to a single, secure, cloud location, eliminating the need to bring users behind corporate firewalls or issue laptops, network IDs, or tokens.

Vault automatically renders all documents with the correct PDF standards for submission publishing. Links in a document’s source file are rendered as blue clickable text, and users can navigate web links, cross references, and tables of contents directly from the viewer—eliminating the need to download files when viewing submission content.

Breakthrough Usability

Vault provides a clean, intuitive interface that is easy to navigate and requires minimal training. The user experience is modeled after consumer websites like Amazon.com and LinkedIn and is updated as needed to stay current and fast.

Real-time Visibility

In any regulatory environment, it is critical to know what content exists, what state it is in, and where it has been used. Users drill down through real-time, interactive reports to answer questions about progress and readiness.

Affordable for All

With Vault Submissions, there are no servers to buy or maintain, no software upgrade projects, and system validation costs are dramatically reduced. And with scalable pricing, Vault Submissions is affordable for even the smallest organizations.

Configurable submissions content plans define what’s needed so you know what’s missing.

Solving the Affiliate Challenge

Globalization is increasing the complexity of regulatory information management. Many companies have difficulty recording and reporting what affiliates and distributors send to local health authorities. Status updates are often collected via email and manually recorded in spreadsheets. Affiliates spend hours duplicating data entry, updating status reports, and responding to questions from headquarters. Vault Submissions addresses these challenges with a global system for content distribution and tracking, enabling you to:

• Increase visibility into documentation sent to local authorities.
• Ensure the use of current approved materials.
• Improve adherence to country-level regulations and commitments.

Interactive dashboards help managers identify and remedy process bottlenecks.

How Vault Helps

• An intuitive interface and reliably high performance enable casual users to input documents and updates directly into Vault.
• Predefined distribution workflows ensure activities are compliant with SOPs.

When used in conjunction with other Vault applications, such as Vault eTMF and Vault QualityDocs, Vault Submissions provides additional efficiencies and control over submission documents. A number of cross-Vault capabilities make life easier for the regulatory team. Cross-Vault search empowers users to find authorized content from other departments. CrossLink documents can be statically or dynamically linked to source materials such as clinical documents, manufacturing details, SOPs, and promotional materials. The “My Vaults” page displays open tasks across Vaults, so other Vault users see a visual reminder of outstanding tasks from regulatory. Taken together, the cross-Vault capabilities streamline interactions between departments, enabling each group to manage content within their own context, while maintaining a single source of truth across the enterprise.

• Affiliate-specific views, searches, and reports improve usability and minimize the need for training.

Submission Content Across the Enterprise

• Integrated reporting eliminates manual recordkeeping and auto-generates compliance documentation.