Digital Process Validation for Faster Speed to Market

Kneat Gx | Paperless Validation

Kneat’s process validation solution removes 100% of paper from validation processes, enables real-time review and approval, and reduces cycle times by 80%. See for yourself in a personalized demo!

Why Kneat

Use Proven Technology and Validation Industry Expertise to Support Your Process Validation Program

  • Risk-based, lean, lifecycle approach to process validation.
  • Productivity improvement of up to 100% and cycle time savings of up to 50%.*
  • Eliminates 100% of paper-records, physical storage, retrieval, and associated costs.
  • Digitalized test execution with integrated deviation management.
  • 21 CFR Part 11/EudraLex Annex 11 compliant.
  • ALCOA+ data integrity best practice.
  • Comprehensive audit trail with detailed, un-editable change log.
  • Instant macro and micro visibility into all aspects of the process in real time.
  • Protocol-based GDP errors minimized.
  • System status monitoring: validated, review due/complete, etc.

*As found by multiple independent customer benchmarking studies.

Kneat Gx Process Validation Solution Overview

Discover how to manage all your products’ life cycle requirements in one easy-to-use solution.

GET SOLUTION OVERVIEW

 


 

What Our Customers Say

“Our partnership with Kneat was one of the critical factors for success. The minute we started our collaboration we felt so comfortable with each other…with Kneat it was very apparent. Based on our learnings from other systems deployments, we see how important it is, not just to have a robust relationship with the vendor – but to have a robust vendor.”

Global Executive Director, QMS Technology Transfer & Commercialization, Merck Sharp & Dohme


“The biggest thing with Kneat was that it was easy to use…Kneat just seemed like it was a faster learning curve, and that people would be able to just jump in and use it…that is the experience that we have had, and we are really happy with our selection.”

Manager, Quality Assurance Validation, ElevateBio


“Our partnership with Kneat will further enable us to help our clients disrupt the marketplace with more agile, leaner, and standardized validation lifecycle management solutions and services…we are excited to work with Kneat to further catalyze the digital journey of our clients and enhance overall quality confidence and speed.”

Executive Vice President, Head, Life Sciences & Healthcare Vertical, HCL Technologies


 

Benefits of Kneat Gx for Process Validation

Kneat Gx digitalizes every step of process validation, accelerating production by reducing cycle times, enhancing data integrity and compliance, and streamlining analysis so validation can be easily managed from anywhere.

Kneat Gx allows you to manage all your products’ lifecycle starting with Critical Quality Attributes and Critical Process Parameters through to Validation Final Reports in one easy-to-use platform.

The Kneat Gx platform’s built-in validated features and functions support all types of documentation and can be easily set up to meet your company’s specific requirements without the need to purchase additional software or modify the application.

Sample Document Types

  • Validation Master Plan
  • Design Documents (Process Control Strategy)
  • Risk Assessment
  • Test protocols (PV)
  • Validation Summary Report
  • Validation Final Report
  • Operational Forms
  • Decommissioning

Documentation generation is simplified in Kneat Gx by pre-approved templates and dynamic data sharing, which reduces time required to generate a document and human errors by auto-populating relevant data in templates and using unique IDs across document packs to enable quick referencing to documents.

Paperless execution reduces GDP errors and improves data integrity by providing standard functionality that supports ALCOA+ principles. In addition, Kneat Gx supports global harmonization and standardization to further reduce time required to deploy a new instrument or the time out of service for changes or upgrades. Such standardization can be done on a large scale, or more focused, so as to fit your needs.

Additional efficiencies are gained since the Kneat Gx work process does not require the transporting of physical documents and these documents cannot be lost or damaged.

 


 

Kneat Gx Validated Features

Changes to deployed work processes or addition of new work processes to Kneat Gx can be performed by a trained user within your organization simply by using Kneat Gx’s standard validated features. These changes can be performed with minimal verification without introducing risk to your program.

Standard Kneat Gx features and functionality include:

  • Critical Requirements and Parameter Management
  • Requirements Traceability Matrixing
  • Dynamic Data Sharing
  • Real-Time Documentation Metrics
  • Status Monitoring and Periodic Review Management
  • Template Management and Approval
  • Work Process Management
  • System Register Management

Request A Personalized Demo

Learn why Kneat Gx is the right choice for you.

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Contact

Talk to us

Find out how Kneat can make your validation easier, faster, and smarter.
Start your paperless validation revolution by speaking to our experts.

Europe: +353-61-203826
U.S: +1 888 88 KNEAT
Canada: +1 902 706 9074