Analytical test method validation

Procedure, equipment, change

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’s e-Validation solution will centralize, digitize and simplify your test method validation process.

 

Kneat manages all your test method validation activities:

  • 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
  • Part 11/Annex 11 environment

The benefits are many: from cycle time and cost reductions to quality and compliance

  • Productivity Improvement and cycle time savings
  • Consistent implementation approach and reporting
  • Information sharing across sites becomes the norm
  • Paper records are eliminated – instant access to all records
  • Greater data integrity
  • Instant macro and micro visibility into all aspects of the process in real time
  • GDP errors minimized
  • Audit ready in real time
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