Installation qualification establishes that the instrument is received as designed and specified, that it is properly installed in the selected environment, and that this environment is suitable for the operation and use of the instrument.
Installation qualification includes:
- Ensure that all equipment, software, spare parts, accessories are received in good condition.
- Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates).
- Install hardware (computer, equipment, fittings and tubings for fluid connections, columns in HPLC and GC, power cables, data flow and instrument control cables).
- Switch on the instruments and ensure that all modules power up and perform an electronic self-test.
- Install software on computer following the manufacturer's recommendation.
- Verify correct software installation, e.g., are all files loaded.
- Configure peripherals, e.g., printers and equipment modules.
|Installation qualification (IQ)||Квалификация установки|