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Validation & Qualification

Quality assurance

  • Qualification for clean rooms according to GMP and ISO
  • Re-Qualification for plants, systems, devices and equipment
  • Qualification & validation engineering
  • Qualification of new equipment, devices and systems (e.g. analytical equipment, process equipment)
  • Preparation of gap analyses
  • Support in the preparation of user requirement specifications, requirement specifications & risk analyses
  • Preparation of the qualification documentation incl. execution of the qualification tests/ QMP, DQ, IQ, OQ, PQ
  • Execution of FAT/SAT
  • Creation of device SOPs
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We accompany you on the path to digitization by providing customized and goal-oriented consulting on the use of solutions based on state-of-the-art technologies.

Frank Schönel

Industrial Engineering & Design