Reply to Thread
We use an off the shelf chromatography data software (which we have fully validated) for running analysis but manually calculate concentrations etc. We are planning to use the CDS to perform custom calculations to remove the need for manual calculations. What level of validation would be required for the custom calculations?
What you propose is the use of pre-defined algorithms for routine calculations. This is analogous to statistical analysis, the best known example of which is SAS programs. For each algorithm or program you should develop test data and pre-calculate the expected outputs prior to running the tests formally with documented records. See: The 5 Most Important Clinical SAS Programming Validation Steps: