Dakota ProfilerDakota Software
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About
Fueled by an integrated regulatory database, Dakota Profiler helps organizations manage local compliance while centralizing their global EHS programs. Leveraging Dakota’s curated Regulatory Database, Decision-Tree-Logic guides users in the creation of site-specific Compliance Profiles. The profile gauge shows how many regulatory domains apply to each site, how many don’t, and most importantly, how many are unknown. Grouped by regulatory domain, Profiler’s clear and concise framework keeps track of the citations included in your tasks to ensure accurate legal registers and comprehensive compliance calendars. Task occurrences are easily managed and tracked to closure in Dakota Tracer. Profiler's regulatory hierarchy uses visual indicators to highlight specific changes and prompt review of affected citations and tasks. Regulatory Alert emails help your teams prepare for coming changes whenever relevant changes are published in the Federal Register.
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About
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market.
Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
For more information, visit our website.
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Audience
Companies seeking a solution to build and maintain proactive EHS compliance assurance programs
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Audience
Medical Devices, Pharmaceuticals, and IVD companies
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Support
Phone Support
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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Company InformationDakota Software
Founded: 1988
United States
www.dakotasoft.com/proactivity-suite/profiler
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Company InformationRegDesk
Founded: 2014
United States
www.regdesk.co
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Categories |
Categories |
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Compliance Features
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation
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Integrations
Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
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Integrations
Active Directory
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
Oracle ADF Faces
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