A fully automated system qualification for analysis of gels and blots

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Kapelan Bio-Imaging works on a module to run complete system validation (PQ) for analysis software LabImage 1D

As analyses become more and more complex, and are increasingly automated while at the same time having to comply with the highest international standards, the requirements for system validation are also becoming ever greater. For this reason, Kapelan Bio-Imaging has been working hard to provide documented proof that their laboratory diagnostics software reliably meets all regulatory requirements, both now and in the future. This proof serves to ensure that the programs, as installed and operated at the customer’s site, permanently comply with the predetermined criteria and that the results obtained reliably meet their specifications. To achieve this, in addition to the mandatory Installation Qualification (IQ) and Operational Qualification (OQ), Performance Qualification (PQ) must be applied to transfer the customer’s processes to the software or to set up the software for use with the customer’s processes. Kapelan Bio-Imaging stands for consistently high quality measurement results and reliable laboratory diagnostics at the highest level and would like to prove this in a transparent manner.

For this reason, Kapelan Bio-Imaging has already been working on the realization of an extension for LabImage 1D. LabImage 1D is a flexible software solution for the partially automated analysis of 1D gels and Western blots. Using a generic 1D gel, it should be possible to check the evaluation process fully automatically by comparing the target and actual values. This special generic calibration gel shows clearly defined bands of different intensity on traces with graded background coloration. The values of these bands are determined by measuring the optical density (OD). These values are then compared with the determined actual values to confirm the analytical performance. Particularly practical at this point is the use of a transmitted light scanner, which can be combined with the LabImage software and controlled directly from it via Scan Interface. With this extension, it will be possible for the first time to carry out a complete evaluation process from scanning, calibration to evaluation on a customer-side installation.