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Description
Regardless of the industry, businesses, governmental entities, and communities globally are facing a dynamic regulatory environment, which includes issues such as international data privacy and the need to harmonize economic advancement with the transition to a low-carbon economy. This evolving landscape brings about shifts in regulations and intensifies both government oversight and public scrutiny regarding how businesses operate and adhere to compliance standards. Totum focuses on providing cloud-based compliance management solutions. Initially designed for the heavily regulated oil and gas sector, Totum Compliance offers a comprehensive and automated method for addressing compliance needs at both local and global levels, ensuring that operational teams receive pertinent and timely information. By establishing a unified source of truth, we empower organizations to effectively navigate the intricate and extensive array of obligations required to uphold their legal and social licenses to operate, regardless of their location on the globe. This ultimately enhances their capacity to adapt to regulatory changes and meet stakeholder expectations efficiently.
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
Microsoft Azure
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
Totum Compliance
Founded
2013
Country
New Zealand
Website
totumcompliance.com
Vendor Details
Company Name
DDi
Founded
1997
Country
United States
Website
www.ddismart.com
Product Features
Oil and Gas
Compliance Management
Equipment Management
Inventory Management
Job Costing
Logistics Management
Maintenance Management
Material Management
Project Management
Resource Management
Scheduling
Work Order Management