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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.
Description
Break down your regulatory and contractual responsibilities into specific tasks that can be assigned and effectively monitored using interactive dashboards. Explore each business sector to pinpoint areas of vulnerability, then categorize potential risks and develop strategies to mitigate them. Oversee IT system risks by conducting user access reviews and managing contract renewals diligently. Establish your corporate framework and maintain comprehensive records of all legal and corporate communications with regulatory bodies. Monitor your licensing obligations along with statutory and regulatory reporting using a unified system. Keep meticulous records of any incidents, complaints, and breaches that may arise. Utilize this data to identify significant business risks and implement necessary changes. Ensure all existing controls operate effectively by employing compliance assurance checklists for validation. Gain a deeper understanding of your obligations and delineate the scope of work necessary for your organization's compliance framework. By taking these proactive steps, you can foster a culture of accountability and transparency throughout the organization.
API Access
Has API
API Access
Has API
Integrations
LexisNexis AML Insight
Salesforce
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
$10 per month
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
Vendor Details
Company Name
crlHorizon
Country
Australia
Website
www.clrhorizon.com
Product Features
Product Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment