Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.
Description
Kivo offers an innovative solution for sponsors and CROs, providing an economical document and process management platform that enables life sciences teams to efficiently accomplish their tasks within a single, user-friendly, and compliant environment. By integrating DMS, RIM, QMS, eTMF, and eCTD functionalities, Kivo allows teams in pharmaceuticals, biotechnology, medical devices, and biologics to handle regulated documents, quality management activities, clinical trial documentation, regulatory submissions, and workflow processes without the hassle of using multiple disconnected tools. With Kivo’s Document Management System, users can manage controlled documents and automate processes while ensuring project oversight, corporate documentation, and readiness for due diligence in a centralized manner, featuring version control, collaboration tools, audit trails, search capabilities, workflow automation, and Part 11-compliant electronic signatures. Additionally, the RIM system enhances project management and correspondence, facilitates submission building and publishing handoff, provides eCTD viewing options, and streamlines dossier management and interactions with health authorities. Overall, Kivo equips life sciences teams with the necessary tools to maintain compliance and efficiency in their operations.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Docusign
No
Gmail
No
Jama Connect
No
Jira
No
Microsoft 365
No
Microsoft 365 Copilot
No
Microsoft Excel
No
Microsoft SharePoint
No
Microsoft Word
No
Integrations
Docusign
Yes
Gmail
Yes
Jama Connect
Yes
Jira
Yes
Microsoft 365
Yes
Microsoft 365 Copilot
Yes
Microsoft Excel
Yes
Microsoft SharePoint
Yes
Microsoft Word
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
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
Yes
Customer Support
Business Hours
No
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
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Kalypso
Founded
2004
Country
United States
Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/
Vendor Details
Company Name
Kivo
Founded
2021
Country
United States
Website
kivo.io
Product Features
Product Features
Document Management
Access Controls
Yes
Archiving & Retention
Yes
Collaboration Tools
Yes
Compliance Tracking
Yes
Document Archiving
Yes
Document Assembly
Yes
Document Capture
Yes
Document Conversion
Yes
Document Delivery
Yes
Document Indexing
Yes
Document Retention
Yes
Electronic Signature
Yes
Email Management
Yes
File Recovery
Yes
File Type Conversion
Yes
Forms Management
Yes
Full Text Search
Yes
Offline Access
Yes
Optical Character Recognition
No
Print Management
Yes
Version Control
Yes