Instrument Validation

Kneat Gx | Paperless Instrument Validation

Instrument Validation, Laboratory Instrument Validation, Lab Equipment Validation

Life Sciences industry regulations require laboratory equipment to be validated and maintained under change control for their full life-cycle.  Failure to demonstrate a state of control can result in regulatory citations, fines, product recall and risk to product license.   

The typical business process to comply with the regulations is a manual, paper-based process that is inefficient, time consuming, labor intensive and susceptible to data integrity and compliance risks.  This paper-based process does not scale and does not support cross site alignment such as leveraging processes and sharing of information.


Kneat Gx | Paperless Instrument Validation

Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire Instrument Validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements.

  • Validation master plan management
  • Systems Register management
  • System Impact assessment
  • Requirements capture and trace-ability management
  • Risk assessment
  • Test protocol development (FAT, SAT, IQ, OQ, PQ/UAT)
  • Paperless test execution with integrated deviation management
  • Validation summary final report
  • Real time validation metrics
  • Validation status monitoring and periodic review management
  • Decommissioning

Why use Kneat Gx for Instrument Validation? 

  • Reduce cycle-times by up to 60%
  • Productivity improvement of up to 100%*
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • Eliminates 100% of paper-records
  • Best practice that can be leveraged over and over across projects and sites
  • Paper records are eliminated – instant central access to all records online
  • Records and versions cannot be misplaced – find and launch the correct record in seconds
  • Potential for data integrity issues is minimized, ‘ALCOA’ principles embedded in the process with focus on the data lifecycle
  • Instant macro and micro visibility into all aspects of the process in real time
  • Protocol GDP errors minimized
  • Comprehensive validation register provides real time inspection preparedness


Client Story:
Biogen Inc.

Biogen's Lab of the Future

The client, Biogen Inc., contracted Kneat to deliver their vision for the future of laboratory operations. Biogen Inc. (previously known as Biogen Idec) is an American multinational biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases.

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Find out how Kneat can make your validation easier, faster, and smarter.
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