Validation

  • Provision of comprehensive support for process, cleaning, analytical method, and software validation.
  • Compilation of Validation Master Plans for specific projects or facilities.
  • Preparation of protocols and reports.
  • Execution of validation exercises and co-ordination of validation activities with associated departments, ensuring adherence to pre-determined  timelines.
  • Review of existing validation data and files versus current standards and requirements, and where appropriate, provision of a gap analysis report.
  • Preparation of relevant procedures and documents supporting the validation system and facility, process and/or method.