Anatox

Instrument Qualification by AIQ-Tool® Software Installation Qualification is carried out as a part of the 4Q model of regulations by USP and GxP, to confirm the instrument is installed according the manufacturer recommendations. The procedure summarises all relevant information for documentation of the process of placing into operation. Operational Qualification is carried out at service intervals to verify the performance criteria according to regulations by USP and GxP, to confirm the instrument satisfies its agreed metrics, is valid in the working environment by verification against traceable references. The engineer will: Assure the system is functioning to acceptable limits by testing relevant instrument test parameters and ranges as determined by AnaTox Operational Qualification protocol. At the completion of the OQ all of the operational tests are documented, results validated, all relevant certificates completed and digitally signed. Once completed the scheduling of service and calibration intervals are then diarised automatically to ensure completion at the next interval. Typical test procedures for a HPLC system – Pump flow rate accuracy and precision – Gradient composition, accuracy and linearity – Detector UV/Vis, PDA/DAD and fluorescence detector wavelength accuracy – UV/Vis, PDA/DAD, fluorescence, refractive index response linearity and noise – Autosampler injection volume precision and carry-over – Column oven and tray temperature accuracy Typical test procedures for a GC system – Inlet leak test and pressure accuracy – Oven temperature accuracy and precision – Detector(s) flow rate accuracy – Oven temperature stability Credits: https://anatox.de/#/Credits