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1: Pharm Acta Helv. 1998 Feb;72(6):343-8.Links

Validation of computer systems: practical testing of a standard LIMS.

Friedli D, Kappeler W, Zimmermann S.

Spirig AG, Froschacker, Egerkingen, Switerzerland. szimmerm@cilch. jnj.com

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.

PMID: 9556435 [PubMed - indexed for MEDLINE]