Design and Validation of Computer Software for Teratology and Reproductive Toxicology Studies

Abstract

Computers have become very popular for collecting and analyzing data from toxicology studies. Software for this purpose is often written by individuals who may not be completely aware of the idiosyncrasies and peculiarities of toxicology data. This is particularly true of teratology and reproductive toxicology studies that have their own unique terminology whose definition often varies from laboratory to laboratory. Thus, it is essential that each laboratory spend some time in understanding the software that they have installed and subject it to a rigorous validation procedure to ensure that the software is doing the job that it was supposed to do and that the data are being properly collected and stored. A system of data entry and a set of procedures used to validate various programs in our laboratories are described.