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Description
Kneat Gx is a cloud-based validation lifecycle management platform developed by Kneat Solutions for organizations operating in regulated life sciences industries. The software digitizes validation activities by replacing paper-based documentation, manual testing processes, and disconnected approval workflows with a centralized electronic system. Its configurable workflows support computer system validation, equipment qualification, cleaning validation, process validation, and other GxP activities. Users can create and manage requirements, risk assessments, validation plans, protocols, test scripts, and summary reports within the platform. Automated requirements traceability matrices connect requirements, risks, and test evidence to help teams monitor validation coverage and identify gaps. Electronic test execution, digital signatures, approval workflows, and secure audit trails support compliance with applicable regulatory requirements. Kneat Gx includes AI-powered tools for generating validation documentation, reviewing records, and retrieving information through natural language questions. Its reporting dashboards provide visibility into validation progress, outstanding tasks, document status, and operational performance across projects and locations. The platform also offers configurable templates, document management, equipment data management, and API integrations to support standardized validation processes throughout an organization.
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
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API Access
Has API
No
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Integrations
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Integrations
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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
Yes
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
Yes
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
Kneat
Founded
2006
Country
Ireland
Website
kneat.com
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No
