Method Validation

Kneat Gx | Paperless Method Validation

Method Validation

Life Sciences industry regulations require validation and change control for Analytical Test Methods used for analysis of product and product components.  Test methods must be well defined, well characterized for precision and accuracy and validated, including formal design review to authenticate methods are suitable for intended use.  Instruments/equipment used to perform analysis must also be validated and maintained under change control.  Methods must be assessed for factors that may cause variation and may lead to inaccurate results.  Much data, including scientific studies and continuous monitoring, is required to support validation results.

Typical business processes to comply with the regulations are time consuming, labor intensive and are susceptible to data integrity and compliance risks that include compilation and assessment of comprehensive sets of data.  Test methods are usually developed early on by R&D and transferred to operations for routine use.  Analytical test methods must be well defined and supported with validation data to assure effective and compliant test method transfer and subsequent test method maintenance.

 

Kneat Gx | Paperless Method Validation

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

  • Validation master plan management
  • Design review
  • Requirements capture and management
  • Risk assessment management
  • Protocol development & management
  • Document review & approval
  • Paperless test execution with integrated deviation management
  • Validation summary report
  • Real time validation status & metrics
  • Periodic review
  • Change management and re-validation

Why use Kneat Gx for Method Validation?

  • Facilitates best practice risk-based, lean, life-cycle approach to validation
  • Eliminates 100% of paper-records
  • Paperless test execution with integrated deviation management
  • Productivity improvement of up to 100%*
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • ‘ALCOA’ Data Integrity best-practice
  • Instant macro and micro visibility into all aspects of the process in real time
  • Protocol GDP errors minimized
  • System status monitoring – validated, review due/complete, etc.
  • Audit ready in real time

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