Regulatory Solutions

Streamline product registration management

Vault Registrations digitizes product registration management within a single cloud-based system, enabling medtech companies to easily plan, track and report on product registrations in one place. With dynamic dashboards and automated reports, the product registration software gives regulatory affairs teams complete oversight and control of all current and planned market activities and Health Authorities' commitments.

Benefits

Improved Data Quality

Improved data quality by reducing data duplicates and discrepancies

Global Visibility

Better visibility into the marketing status of a company’s global product portfolio

Faster Responses to Health Authorities

Faster responses to Health Authorities through query and commitment tracking

Unified RIM

Connection to a unified Vault RIM Suite of applications that improves end-to-end process efficiency

Features

Global Product Registrations

Manage registration information for marketed products and investigational devices including UDI identifiers, device classifications, indications, packaging specifics, and manufacturing details. Manage license updates and renewals and report on the latest approved details.

Change Management

Track proposed changes to global registrations. Determine the impact of a proposed change and delegate actions to local affiliates to execute the change in their market.

Dashboards and Reports

Create easy, self-serve reports showing information by any combination of attributes including product, application, region, manufacturer and more. Address any bottlenecks or delays by re-assigning tasks or sending reminders directly from within the report.

Affiliate Home Page

Encourage local user adoption with a specific user interface that allows market product owners to view all country-specific data points in a simple graphical format with quick-launch buttons to update local data.

Resources for Vault Registrations

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A Global Application for Product Registration Tracking

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Industry Insight: Current State of Modernization in Regulatory Affairs

Image for Lori Holder shares how Vault RIM provides a single system to automate Alcon’s regulatory processes
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Lori Holder shares how Vault RIM provides a single system to automate Alcon’s regulatory processes

Image for Epredia transformed quality and regulatory operations with Veeva MedTech
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Epredia transformed quality and regulatory operations with Veeva MedTech