What We Do

Clarus Validation Group designs and builds validation programs, providing the documents and training necessary to define, govern and implement a truly turnkey application.  This includes comprehensive programs covering all areas of validation, 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 issues (of technical and/or regulatory origin).  Clarus audits validation programs 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 Validation
  • Facilities (including cleanroom certification and environmental monitoring)
  • Computer System Validation
  • Sterilization
  • Equipment Commissioning, Verification and/or Qualification
  • Change Control
  • Quality Risk Management
  • Analytical Test Methods
  • Microbiological Test Methods
  • Periodic Review and Revalidation

Our Services

  • Validation Program Design
  • Validation Project Management and Execution
  • Auditing
  • Training
  • Staff Augmentation