VALIDATION OF COMPUTERIZED LIQUID-CHROMATOGRAPHIC SYSTEMS

Almost all vendors of liquid chromatographs offer dedicated computer-b ased controller/data-processing systems. These systems are integrated into the operation of the equipment and frequently use proprietary sof tware systems for which complete documentation and program listings ar e not available to the user. In some instances, data in magnetic media are considered to be ''raw data'' for regulatory retention requiremen ts. in addition, printed copies of final data used to make decisions a nd the procedures used to generate these data from raw data must be pr epared and retained. In all cases, the systems must be validated to de monstrate that they are suitable for their intended uses. Approaches t o validation of these systems are described and discussed.