What We Do

Clarus Validation Group designs and builds validation programs and quality systems, providing the documents and training necessary to define, govern and implement a truly turnkey application.  This includes comprehensive programs covering all areas of validation and quality management systems, however, services may be scaled to select areas, depending on client needs.  We also audit and improve existing programs and consult with clients on specific validation and compliance issues (of technical and/or regulatory origin).  Clarus audits validation and other quality systems for compliance to regulatory expectations and industry standards and best practices, presenting risk profiles for identified issues in addition to opportunities for improvement (in compliance, efficiency, and effectiveness).

All Facets of Validation

  • Process Validation – all stages (Process Development, Process Qualification and Continued Process Verification using Quality by Design Principles)
  • Cleaning and Sterilization Validation
  • Facilities Qualification (including cleanroom certification and environmental monitoring)
  • Risk-Based Equipment Commissioning and Qualification
  • Test Method Validation
  • Periodic Review and Revalidation
  • Routine Product and Process Monitoring and Quality Metrics
  • Change Control
  • Quality Risk Management
  • Supplier Qualification and Material Management
  • Investigation and CAPA

Our Services

  • Validation Program Design and Development
  • Validation Project Management and Execution
  • Auditing
  • Training
  • Quality System Design and Development