7.3 Verification and Validation of Measuring Device
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7.3 Verification and Validation of Measuring Device
Measuring equipment, before being placed into service, should be checked to establish that it meets the laboratory’s specification requirements. It should be therefore
subjected to formal acceptance, meaning that it should be entered into the record, be
assigned the appropriate identification number, and assigned the adequate metrology
status (i.e., calibration, testing). In technical terms, the equipment should be checked
for its technical specifications, compliance with the environmental requirements of
the manufacturer, and then calibrated to its assigned metrological status. In order to
performed the primary examination of the given equipment, tests are carried out by
using pure chemicals in most cases. This allows the performance of the device to be
monitored under standardized conditions. It is of course expected that the equipment
should be operated by qualified and authorized personnel.
Once enrolled, the device should undergo monitoring of its performance and stability—thus, the maintenance plan should be created. The basic criterion for establishing the frequency of the check of the performance should be that intervals are
shorter than the time in which the deviation of key parameters can go beyond acceptable limits (which can be evaluated on the basis of laboratory experience or risk
assessment).
7.4 Validation of the Measurement Device Software
The validation of software used for controlling the system should be the task of the
manufacturer. The laboratory may require the supplier to deliver a validation report;
moreover, the manufacturer should provide assistance in the periodic testing of the
software, or of providing test packets, allowing the user to independently verify the
operation of the system according to the specification. In practice, many modern
devices have inbuilt package tests, which check the computer system each time after
starting.
A common practice of manufacturers is updating the software that controls the
device; thus, revalidation is required in the case of any modification or change.
Updating the software may affect the mode of operation of both the computer and
the measuring device, so it is necessary to have evidence, indicating that the updated
version of the software has undergone a process of re-validation.
7.5 Validation of Procedures for Processing the Results
In order to obtain the final results, first the calibration of the given equipment should
be done; then the measurement for the set of test samples can be performed, resulting in raw data (signals) that can then be subjected to processing. In practice, raw
data collected are subjected to various mathematical procedures, which use different
91
7.3 Verification and Validation of Measuring Device
Measuring equipment, before being placed into service, should be checked to establish that it meets the laboratory’s specification requirements. It should be therefore
subjected to formal acceptance, meaning that it should be entered into the record, be
assigned the appropriate identification number, and assigned the adequate metrology
status (i.e., calibration, testing). In technical terms, the equipment should be checked
for its technical specifications, compliance with the environmental requirements of
the manufacturer, and then calibrated to its assigned metrological status. In order to
performed the primary examination of the given equipment, tests are carried out by
using pure chemicals in most cases. This allows the performance of the device to be
monitored under standardized conditions. It is of course expected that the equipment
should be operated by qualified and authorized personnel.
Once enrolled, the device should undergo monitoring of its performance and stability—thus, the maintenance plan should be created. The basic criterion for establishing the frequency of the check of the performance should be that intervals are
shorter than the time in which the deviation of key parameters can go beyond acceptable limits (which can be evaluated on the basis of laboratory experience or risk
assessment).
7.4 Validation of the Measurement Device Software
The validation of software used for controlling the system should be the task of the
manufacturer. The laboratory may require the supplier to deliver a validation report;
moreover, the manufacturer should provide assistance in the periodic testing of the
software, or of providing test packets, allowing the user to independently verify the
operation of the system according to the specification. In practice, many modern
devices have inbuilt package tests, which check the computer system each time after
starting.
A common practice of manufacturers is updating the software that controls the
device; thus, revalidation is required in the case of any modification or change.
Updating the software may affect the mode of operation of both the computer and
the measuring device, so it is necessary to have evidence, indicating that the updated
version of the software has undergone a process of re-validation.
7.5 Validation of Procedures for Processing the Results
In order to obtain the final results, first the calibration of the given equipment should
be done; then the measurement for the set of test samples can be performed, resulting in raw data (signals) that can then be subjected to processing. In practice, raw
data collected are subjected to various mathematical procedures, which use different