Validation of a Digital Data Acquisition and Analysis System in a Cardiovascular Toxicology Laboratory

The procedure used to validate a vendor-supplied computerized data acquisition and analysis system in a cardiovascular toxicology laboratory is described. This system is used to collect and analyze raw signals from cardiovascular studies performed in chronically instrumented, conscious experimental animals. Definitions of raw and derived data as they apply to studies performed according to Good Laboratory Practice Regulations were developed. The data acquisition function of the system and the algorithms that compute derived parameters were validated through the creation of validation data sets from instrumented animals subjected to drug infusions. Computer-generated parameter values were compared statistically against manually generated values to verify the accuracy and precision of the system. The time averaging function of the system was validated by comparing beat-by-beat values against 1- and 10-min running averages from the same experiment. The system was successfully validated for the analysis of cardiac left ventricular pressure, systemic arterial pressure, myocardial dimensions and electrocardiogram-derived heart rate. The principles and methods used in the validation of this vendor-supplied computerized data acquisition and analysis system should be applicable to a wide variety of systems that are being developed for non-clinical pharmacology and toxicology studies.