title: Validation of computer systems: practical testing of a standard LIMS.
abstract: In recent years the introduction of computer systems for data handling in the pharmaceutical industry has increased. A standard LIMS (laboratory information management system) is software commercially available from different suppliers not only to facilitate data handling in laboratories but also to cover GMP-requirements. Computer systems introduced in GMP-areas of pharmaceutical companies have to be validated. For a standard LIMS, the general validation of the program is performed by the supplier. Nevertheless, the user is always required to cover all phases of a validation. The objective of this paper is to discuss suitable test procedures for the most critical functions of a standard LIMS needed during the verification step of the validation process.
authors.affiliation: Spirig AG, Froschacker, Egerkingen, Switerzerland. szimmerm@cilch. jnj.com
authors.forename: D
authors.initials: D
authors.lastname: Friedli
authors.forename: W
authors.initials: W
authors.lastname: Kappeler
authors.forename: S
authors.initials: S
authors.lastname: Zimmermann
mesh_terms: D002984:Clinical Laboratory Information Systems / Q000592:standards*; D003199:Computer Systems / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D012986:Software Validation