Our approach is unique

• We use a one standard approach irrespective of instrument manufacturer and model.
• Instrument acceptance criteria and specifications can be changed and saved for future qualifications.
• We capture all the data electronically
• NIST traceable standards.
• Data traceability
• All SOPs and Raw data is combined under one large document effortlessly and seamlessly

Liquid Chromatograph

• Pump flow rates
• Gradient Tests
• Temperature accuracy
• Autosampler precision & carry over
• Injection linearity
• Wavelength accuracy (U/V, Fluorescence)
• Wavelength linearity (U/V, Fluorescence)

Gas Chromatograph

• Column Oven Temperature Accuracy and Precision
• Temperatures:
  • Inlet (front & rear)
  • Detector (front & rear)
• Inlet pressure and tightness
• Flow rate
• Detector gas flow rate
• Precision FID/TCD linearity.

ISPE Baseline Guide, Volume 5 Commissioning and Qualification definition:

“The documented verification that all aspects of a facility, utility, or equipment that can affect product quality operated as intended throughout all anticipated ranges.”