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What is ViSU?

ViSUâ„¢ is a cutting-edge cloud platform designed for comprehensive End-to-End Regulatory Information Management (RIM) specifically for the medical device industry, enabling users around the globe to easily access and manage crucial Regulatory Data, such as Product Master information, Registrations, and Tracking. This all-encompassing tool also supports the organization of Dossiers and Technical Files through effective submission planning, development, and lifecycle oversight, while enhancing communication with Health Authorities and Notified Bodies, monitoring obligations, managing Unique Device Identification (UDI), and overseeing electronic Instructions for Use (eIFU), in addition to maintaining a Regulatory Requirements Database and controlling modifications. By implementing ViSU, companies can fully leverage the advantages of digital transformation in their regulatory practices, leading to improved connectivity, greater traceability, and extensive automation. Ultimately, ViSU plays a vital role in boosting regulatory management efficiency, mitigating compliance risks, and decreasing operational expenses, establishing itself as a crucial resource for the sector. Furthermore, the platform's intuitive interface ensures that teams can effortlessly navigate the intricate landscape of regulatory requirements, thereby enhancing overall productivity. This ease of use combined with powerful functionalities positions ViSU as a game-changer in the regulatory management arena.

What is Kivo?

Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.

Media

Media

Integrations Supported

Docusign
Gmail
Microsoft Word

Integrations Supported

Docusign
Gmail
Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$1,800 per month
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

DDi

Date Founded

1997

Company Location

United States

Company Website

www.ddismart.com

Company Facts

Organization Name

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

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