Validation of computerized systems in pharmaceutical analytical laboratories

Validation of computerized analytical systems used in pharmaceutical laboratories is required by many regulations and company policies. This article guides quality assurance and laboratory managers and users of computer-controlled analytical instruments through the entire validation process from selecting the vendor and installation to ongoing calibration and performance qualification. It also gives guidelines on how to evaluate and validate existing computerized systems retrospectively and how to validate software developed by the user to further customize a system purchased from a vendor.