Posted on Jul 24, 2018
To validate an assay is to measure precision, linearity, accuracy, robustness, system suitability and repeatability. To achieve these results, we conduct multiple experiments in a pre-validation phase with the assay. This phase is a series of 2-4 experiments that specifically look at these capabilities. Once we have advanced an assay, we perform the assay 2 more times for a total of 3 identical repeats. At that point, your assay meets the FDA GLP or GMP requirements.