Now embarking on the final article in his series on method comparisons. Stephen MacDonald concludes with advice on preparation of the documentation and final report.
Method comparisons take on many forms. These can vary from simple lot changes in reagents to full-scale validation and verifications. It may be the replacement of an old piece of kit with a new one. The difference between a method comparison study involving a standard validated method and a bespoke locally constructed method is substantial. And it should be. Whichever method we are using we always end up at the same point – documenting our results and signing of the report so that the evidence is there to ensure we were satisfied with the comparison.
As with the comparison itself, the extent to which documentation is required is related to the method carried out, and of course to your local quality management system requirements. In this article, we discuss some of the important components of the final documentation to consider.
First, we will review the steps we have taken. In doing so, it serves as an excellent framework for what we need to put in the report. We need to be aware of regulatory requirements with which we are aiming to comply. This includes the regulatory requirements required of our suppliers. Using regulatory approved assays, we can already mitigate some of the risk associated with new method implementation.
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