Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.
API Access
Has API
Yes
API Access
Has API
No
Screenshots View All
No images available
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
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
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
Yes
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
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Kivo
Founded
2021
Country
United States
Website
kivo.io
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
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