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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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

Screenshots View All

Screenshots View All

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

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