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What is ViSU?

ViSUâ„¢ is a cutting-edge cloud platform designed for comprehensive End-to-End Regulatory Information Management (RIM) specifically for the medical device industry, enabling users around the globe to easily access and manage crucial Regulatory Data, such as Product Master information, Registrations, and Tracking. This all-encompassing tool also supports the organization of Dossiers and Technical Files through effective submission planning, development, and lifecycle oversight, while enhancing communication with Health Authorities and Notified Bodies, monitoring obligations, managing Unique Device Identification (UDI), and overseeing electronic Instructions for Use (eIFU), in addition to maintaining a Regulatory Requirements Database and controlling modifications. By implementing ViSU, companies can fully leverage the advantages of digital transformation in their regulatory practices, leading to improved connectivity, greater traceability, and extensive automation. Ultimately, ViSU plays a vital role in boosting regulatory management efficiency, mitigating compliance risks, and decreasing operational expenses, establishing itself as a crucial resource for the sector. Furthermore, the platform's intuitive interface ensures that teams can effortlessly navigate the intricate landscape of regulatory requirements, thereby enhancing overall productivity. This ease of use combined with powerful functionalities positions ViSU as a game-changer in the regulatory management arena.

What is Veeva RegulatoryOne?

RegulatoryOne revolutionizes complex, resource-intensive systems by offering an all-in-one regulatory management software solution that addresses all your compliance and regulatory needs, allowing you to quickly adjust to changing regulations. The improved efficiency not only speeds up your market entry but also promotes transparency across your organization at each stage of product development until it reaches market readiness. As a completely cloud-based solution, RegulatoryOne seamlessly integrates and optimizes every facet of the regulatory process, providing you with comprehensive visibility into your products, their sales timelines, and their distribution channels, all from a single interface. This cohesive strategy not only facilitates compliance but also equips your team to make timely and informed decisions. By streamlining workflows, RegulatoryOne helps you maintain a competitive edge while navigating the complexities of regulatory requirements.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support

Customer Service / Support

24 Hour Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

DDi

Date Founded

1997

Company Location

United States

Company Website

www.ddismart.com

Company Facts

Organization Name

Veeva Industries

Date Founded

2007

Company Location

United States

Company Website

www.industries.veeva.com

Categories and Features

Categories and Features

Compliance

Archiving & Retention
Audit Management
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

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