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Average Ratings 19 Ratings

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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

RegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Active Directory No 
Arena No 
Asana No 
Boomi No 
Dynamics 365 Customer Service No 
Jira No 
MuleSoft Anypoint Platform No 
Okta No 
OpenText AI Operations Management No 
Oracle ADF Faces No 
PTC Windchill No 
Qualio No 
Resource Management by Smartsheet No 
SnapLogic No 

Integrations

Active Directory Yes 
Arena Yes 
Asana Yes 
Boomi Yes 
Dynamics 365 Customer Service Yes 
Jira Yes 
MuleSoft Anypoint Platform Yes 
Okta Yes 
OpenText AI Operations Management Yes 
Oracle ADF Faces Yes 
PTC Windchill Yes 
Qualio Yes 
Resource Management by Smartsheet Yes 
SnapLogic Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Contact us to learn more.
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) No 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Dakota Software

Founded

1988

Country

United States

Website

www.dakotasoft.com/proactivity-suite/profiler

Vendor Details

Company Name

RegDesk

Founded

2014

Country

United States

Website

www.regdesk.co

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing Yes 
Environmental Compliance Yes 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance Yes 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation No 

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