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What is Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

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.

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Integrations Supported

Integrations Supported

Docusign
Gmail
Jama Connect
Jira
Microsoft 365
Microsoft 365 Copilot
Microsoft Excel
Microsoft SharePoint
Microsoft Word

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Categories and Features

Life Sciences

Not specified

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
Print Management
Version Control

Life Sciences

Not specified

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