Qualification and validation of software and computer systems in laboratories

 Installation and operational qualification are important steps in the overall validation and qualification process for software and computer systems. This article guides users of such systems step by step through the installation and operational qualification procedures. It provides guidelines on what should be tested and documented during installation prior to routine use. The author also presents procedures for the qualification of software using chromatographic data systems and a network server for central archiving as examples. Received: 31 October 1997 · Accepted: 25 November 1997