Medical Devices

Process Validation

  • Process and related equipment validation, including utilities, computer systems and other automated systems
  • Writing and review of validation master plan and validation protocols
  • Risk assessments and gap analysis
  • Technical investigation of deviations and out-of-specification results
  • Writing and review of CMC sections for global regulatory submissions
  • Hands-on assistance during validation activities (person in plant)
  • Master planning, scheduling and tracking of validation efforts