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Description
Dakota Profiler, powered by a comprehensive regulatory database, assists organizations in navigating local compliance while streamlining their global Environmental, Health, and Safety (EHS) initiatives. Utilizing Dakota's carefully curated Regulatory Database, the platform employs Decision-Tree-Logic to aid users in developing Compliance Profiles tailored to individual sites. The profile gauge reveals the number of regulatory domains applicable to each location, those that are not, and crucially, those that remain unknown. Organized by regulatory domain, Profiler provides a straightforward and organized structure that tracks citations within your tasks, ensuring the creation of precise legal registers and thorough compliance calendars. Users can easily manage and monitor task occurrences until resolved through Dakota Tracer. Additionally, Profiler's regulatory hierarchy features visual cues to signal important changes and prompt necessary reviews of impacted citations and tasks. To keep teams informed, Regulatory Alert emails notify them of upcoming changes whenever pertinent updates are released in the Federal Register, fostering proactive compliance management. Ultimately, Dakota Profiler enhances organizational efficiency and compliance readiness in an ever-evolving regulatory landscape.
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
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
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
Dakota Software
Founded
1988
Country
United States
Website
www.dakotasoft.com/proactivity-suite/profiler
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
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