Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
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