Abstract
The role of laboratory information management systems (LIMS) in analytical method validation is discussed. Method validation experiments should be envisaged as routine sample analysis and the majority of validation parameters such as calibration model selection, precision and accuracy, recovery, range and linearity, limit of quantification (LOQ) and analyte stability can be incorporated within a LIMS. Limits of detection and selectivity are both difficult to incorporate in a LIMS as there is a high degree of human interpretation, which makes it difficult and not cost-effective to automate. Five LIMS pre-requisites are required to automate this process: interfacing of analytical instrument including balances, stock control of analytical reference standards, preparation of standard solutions, analyte stability functionality and interfacing to a statistical package.
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