Streamlined Regulatory Compliance and Information Management
In today's rapidly evolving regulatory landscape, global medical device and diagnostics manufacturers face challenges related to globalization, supply chain complexity, patient safety, and new regulations. These factors can significantly impact the total product lifecycle and lead to manual, cumbersome processes that slow down time to market. Veeva MedTech's Vault RIM Platform offers a comprehensive solution to streamline global regulatory compliance and information management. By unifying systems and providing a single source of truth for registrations management, submissions, publishing, and archival, this platform enables organizations to ensure compliance and accelerate speed to market.
Key Benefits of Vault RIM Platform
The Vault RIM Platform is designed to simplify regulatory processes and drive efficiency across the product development lifecycle. By leveraging this platform, organizations can eliminate or simplify up to 80% of submission creation tasks, save over 200 hours on product approval and renewal reporting, and reduce the time spent on updating country records from 2 hours to just 5 minutes. Testimonials from users like Ryan Nugent, Assoc. Director of Digital QRA Systems, highlight the real-time reporting, ease of access, and reduced compliance risk achieved through interconnected and standardized systems and data.
Real-time Submissions and Registrations Visibility
Veeva MedTech's Vault RIM Platform provides users with real-time access, visibility, and control over regulatory documents, data, and processes. With the ability to track global registrations, understand the status of registrations worldwide, and monitor KPIs in real-time, organizations can proactively manage compliance and adapt to the pace of change. Users can easily author, plan, collect, and approve documents for submission in industry-standard formats, ensuring efficient and compliant global submissions.
The Functionality of Vault RIM Platform
The Vault RIM Platform is a unified group of cloud software applications that offers end-to-end visibility, oversight, and control for regulatory compliance documents, data, and Health Authority correspondence throughout the product development lifecycle. This platform allows users to track product registration data, timelines, and regulatory impacts, plan, author, review, and approve submission documents, hyperlink and validate submissions publishing behind-the-scenes for greater automation and transparency, and store regulatory submission history in the cloud for easy access.
Regulatory Resources and Support
Veeva MedTech provides a range of regulatory resources to support organizations in managing complex medtech regulations and achieving regulatory compliance. From unified RIM applications to buyer's guides, blogs, and white papers, these resources equip users with the knowledge and tools needed to navigate regulatory challenges effectively. By partnering with Veeva MedTech, organizations can ensure the delivery of compliant, quality products to patients efficiently and effectively.