Validation of Computerized Liquid Chromatographic Systems

Open Access
Publisher Website
Google Scholar
Abstract
Almost all vendors of liquid chromatographs offer dedicated computer-based controller/data-processing systems. These systems are integrated into the operation of the equipment and frequently use pro-prietary software systems for which complete documentation and program listings are not available to the user. In some instances, data in magnetic media are considered to be “raw data” for regulatory retention requirements. In addition, printed copies of final data used to make decisions and the procedures used to generate these data from raw data must be prepared and retained. In all cases, the systems must be validated to demonstrate that they are suitable for their intended uses. Approaches to validation of these systems are described and discussed.

This publication has 0 references indexed in Scilit: