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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

RegulatoryOne transforms custom, labor-intensive systems into a comprehensive, singular regulatory management software solution that caters to all your compliance and regulatory requirements, enabling you to swiftly adapt to evolving regulations. The enhancements in efficiency not only accelerate your time to market but also ensure transparency throughout your organization at every product release stage as it progresses to market readiness. As a fully cloud-based regulatory management software, RegulatoryOne integrates and streamlines every element of the regulatory process, granting you clear insights into your products, their sales timelines, and their distribution locations – all accessible from a single platform. This unified approach not only simplifies compliance but also empowers your team to make informed decisions swiftly and effectively.

Description

ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) Yes 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Veeva Industries

Founded

2007

Country

United States

Website

www.industries.veeva.com

Vendor Details

Company Name

DDi

Founded

1997

Country

United States

Website

www.ddismart.com

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance Yes 
HIPAA Compliance Yes 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance Yes 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation No 

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