Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
CLEEN, a trusted software for proactive cleaning validation, is a global leader in digitalizing cleaning compliance processes. CLEEN is used by some of the most prestigious pharma companies around the world. It has helped to resolve regulatory observations and set a gold standard in cleaning validation.
CLEEN is a preferred choice for regulators. It brings consistency, accuracy and harmonization to Cleaning Procedures from beginning to end.
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.
API Access
Has API
Yes
API Access
Has API
No
Integrations
FactoryTalk
Yes
SAP Cloud Platform
Yes
SAP ERP
Yes
TrackWise
Yes
Integrations
FactoryTalk
No
SAP Cloud Platform
No
SAP ERP
No
TrackWise
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
No
Android App
Yes
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
No
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
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Leucine
Founded
2015
Country
United States
Website
www.leucinetech.com
Vendor Details
Company Name
Kneat
Founded
2006
Country
Ireland
Website
kneat.com
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
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