3.3.2 Processes to enable computerized and non-computerized systems being suitable for intended use

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​​​​A. Background & Definitions[edit]

This item refers to one of the Core Requirements (Core Requirement 14 - "Research equipment and tools must be suitable for intended use and ensure data integrity​") and is, therefore, considered as essential.

All equipment and computerized systems (used for the generation, processing, storage and retrieval of data, and for controlling environmental factors) must be appropriate for the measurements to be made and be in good working condition.

The level/frequency of maintenance, testing and calibration should be proportionate to the business risk of malfunction.

Calibration: Set of operations performed to establish a relationship between equipment indicated values and the values of a certified reference standard.


B. Guidance & Expectations[edit]

  • Equipment must be serviced/maintained/calibrated according to manufacturer´s recommendations and these actions must be documented.
  • Computerized systems must be demonstrated to be fit for the required functionality.
  • Best practices:
    • ​Find out from supplier directly or via equipment manual what maintenance is required, the maintenance intervals and what care is required from the user.​
    • ​Computerized systems: Find out who is responsible for the computer maintenance (update on programs and operating system; administrator and user access; backups)​
    • Generating and maintaining a list equipment and computerized systems along with intended use and how to demonstrate suitability along with a logbook for each system (services, calibration, quality control failures, etc.) may help to ensure and demonstrate suitability.
    • It may help to group lab instruments in different groups:
      • Group A (Instruments for which the work precision is not critical to obtain valid test results): the extent of qualification is limited to visual control (e.g. magnetic hot plates, glassware, paraffin dispenser, ….).
      • Group B (Instruments for which the work precision is important to obtain valid test results): qualification requires calibration and periodic control (e.g. volumetric pipette, pH meter, …).
      • Group C (Instruments using commercially available software): qualification requires a qualification plan in line with the criticality of the system, a qualification report and periodic checks as required (e.g. LCMS, FACS, LIMS, …).
    • Assigning a responsible system/equipment owner for ensuring that the instrument is properly qualified.

​PLEASE DO NOT FORGET

  • Keep maintenance and calibration records of equipment.
  • Define frequency and acceptance criteria for calibration (set point, action limit, warning limit).
  • Upon changes to computerized systems, determine the functionality affected by the change and its required post-change testing.
  • Make sure all users are qualified and trained and have access to instructions for adequate use of equipment and computerized systems.


C. Resources[edit]

  • Example of a standard operating procedure: pH meter. HANDBOOK: QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH, Appendix 4 –[1]


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Next item: 3.3.3 Management of research materials and reagents