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What is crlHorizon?

Break down your regulatory and contractual duties into distinct tasks that can be allocated and efficiently tracked through interactive dashboards. Delve into each business sector to identify potential vulnerabilities, categorize associated risks, and formulate strategies aimed at their mitigation. Supervise IT-related risks by performing user access audits and diligently handling contract renewals. Create a corporate framework while maintaining thorough records of all legal and corporate correspondences with regulatory authorities. Keep a close watch on your licensing requirements alongside statutory and regulatory reporting using an integrated system. Document all incidents, complaints, and breaches meticulously as they occur. Leverage this information to recognize major business risks and execute necessary adjustments. Validate the effectiveness of all existing controls by utilizing compliance assurance checklists. Strive to gain a comprehensive understanding of your obligations and outline the necessary work scope to ensure your organization meets compliance standards. By implementing these proactive measures, you can cultivate a culture of accountability and transparency across your organization, enhancing overall operational integrity and trust. This approach not only safeguards against potential risks but also ensures long-term sustainability and success.

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.

Media

Media

Integrations Supported

LexisNexis AML Insight
Salesforce

Integrations Supported

LexisNexis AML Insight
Salesforce

API Availability

Has API

API Availability

Has API

Pricing Information

$10 per month
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

crlHorizon

Company Location

Australia

Company Website

www.clrhorizon.com

Company Facts

Organization Name

DDi

Date Founded

1997

Company Location

United States

Company Website

www.ddismart.com

Categories and 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

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