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)
- ...