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 (5). Table 2 lists steps as recommended before and during installation.
- Compare equipment, as received, with purchase order (including software, accessories, spare parts)
- Check documentation for completeness (operating manuals, maintenance instructions, standard operating procedures for testing, safety and validation certificates)
- Check equipment for any damage
- 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. Utilities to do this should be included in the software itself.
- Make back-up copy of software
- Configure peripherals, e.g. printers and equipment modules
- Identify and make a list with a description of all hardware, include drawings where appropriate.
- Make a list with a description of all software installed on the computer
- List equipment manuals and SOPs
- Prepare an installation report
For a larger laboratory we recommend entering the equipment data into a spreadsheet or data base. Items that should be included for each piece of equipment are listed in table 5.
- In-house identification number (asset number)
- Name of the item of equipment
- The manufacturer’s name, address and phone number for service calls, service contract number, if there is one
- Serial number and firmware revision number of equipment
- Computer hardware with information on the processor, hard disk space, memory and the monitor
- Software with product and revision number
- Date received
- Date placed in service
- Current location
- Size, weight
- Condition when received, for example, new, used, reconditioned
- List with authorized users and responsible person