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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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

ZenQMS is an electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO organizations. The cloud-based, AI-enabled, fully validated platform is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management Corrective and Preventive Actions Deviations, non-conformances, complaints, issues, and other quality events Change controls Audit management Critical quality workflows Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft Azure No 
Okta No 
Res_Q No 

Integrations

Microsoft Azure Yes 
Okta Yes 
Res_Q Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

ZenQMS does not charge per seat license, allowing you to grow without sacrificing compliance. Our pricing is simple and transparent, and is based on the complexity of the account and initial migration/configuration activity. Contact ZenQMS today for more details.
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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Kneat

Founded

2006

Country

Ireland

Website

kneat.com

Vendor Details

Company Name

ZenQMS

Founded

2010

Country

United States

Website

www.zenqms.com

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 

Product Features

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

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