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Our main assets to develop your equipment qualification projects: An extensive knowledge of regulatory documents and analytical expertise

Equipment Qualification

  • Risk analysis
  • Defining and structuring a qualification strategy (DQ, IQ, OQ, PQ)
  • Design of qualification documentation : protocols, test scripts, reports
  • Tests run
  • Training
  • Audit of your equipment qualifications

QUALILAB’s main equipment qualification references (software part):

  • HPLC (Millenium, Empower 2, Atlas...)
  • LC/MS (Masslynx, Analyst)
  • UV/Vis (Agilent Chemstation, Cary)
  • Thermal analysis (PYRIS)
  • Fluometric, colorimetric, spectrophotometric, PIRs, Karl Fisher systems
  • Automats (Winprep, Hamilton, TPW II, Multidose (Zymark - Caliper))
  • Autoclave monitoring (LEQUEUX, SOFAST, GETINGE, OP win, Validator)
  • Monitoring of interprocess systems for testing of: hardness, desiccation, friability, compression, granulometry, ... (ERWEKA, RETSCH, METTLER TOLEDO, KORCH)
  • Telemetry systems (GLOUD/LDS – PONEMAH system)
  • Systems for Clinical laboratories (KONELAB 20 XTi, ACL 9000)
  • ...
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