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features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

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 

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