IQ for analytical equipment qualification

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Installation qualification

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.

Before installation

  • Obtain manufacturer's recommendations for installation site requirements.
  • Check the site for the fulfillment of the manufacturer’s recommendations (utilities such as electricity, water and gases and environmental conditions such as humidity, temperature, vibration level and dust).
  • Allow sufficient shelf space for the equipment, SOPs, operating manuals and software.[b] During installation
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    • 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
    One question that frequently arises is whether any type of testing should be done as part of IQ. Functional and operational testing belong to OQ. IQ should only include tests to verify that the software and hardware are installed properly and that all electrical and fluid connections are correct. Therefore IQ should include switching on the instrument and checking for any error messages. Correct loading of computer software should be checked by suitable verification software. For a system that consists of several modules, such as a modular HPLC system, IQ can include injection and qualitative evaluation of a standard. In this way the correct installation of all fluid and electrical tubings and cables can be checked.