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
- Pump flow rates
- Gradient Tests
- Temperature accuracy
- Autosampler precision & carry over
- Injection linearity
- Wavelength accuracy (U/V, Fluorescence)
- Wavelength linearity (U/V, Fluorescence)
- Column Oven Temperature Accuracy and Precision
- 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.”