OneCheck AutoCalibration and AutoValidation Module

Analytical instruments used in regulated industries are increasingly required to comply with validation processes through the use of IQ/OQ/PQ protocols. This has resulted in a number of initiatives (PAT, CFR21 part11, GLP), whose aim is to ensure the validity, the integrity and the precision of the measurement. The OneCheck package provides hassle-free validation methods for the XploRA system, to comply with these requirements and to ensure the most reliable results.

The OneCheck module uses with a factory-set reference sample, and the parameters are completely pre-configured within the software, so that no decisions need to be made by the user. Simply load the sample, and run the OneCheck function – the software does everything else.  OneCheck can even be scheduled periodically during the system’s downtime (e.g. at night) to optimize working time.

AutoCal Function

A number of factors can compromise proper calibration of the system (high temperature variations, mechanical vibrations, environmental constraints, etc). The AutoCal function of the XploRA automatically compensates any potential variations to ensure correct frequency labeling.  The system is not only calibrated in frequency, it also calibrated in intensity, so that spectra of the same sample have the same peak ratios with the different lasers. This makes it easier to compare spectra and perform spectral identification.

AutoVal Function

The AutoVal function goes a step further by automatically checking the performance of the instrument. If misalignment ever occurs, it is possible that calibration routines alone do not detect it. Confocality and optical throughput may be compromised. AutoVal systematically checks that the reference signal intensity is beyond a pre-defined minimum and that the requirements are met for a true confocal measurement. If the AutoVal routine fails, it results in a red flag informing the operator that the system does not meet all the requirements for validated results. The reference spectra recorded during the routine are stored in a log file accessible by the operator, in order to help trouble-shooting. It also allows monitoring the system evolution and preventing possible failures.