Validation of a laboratory information management system (LIMS) is becoming an increasingly important issue for many laboratories. A host of guidelines such as Good Laboratory Practice (GLP), Good Automated Laboratory Practice (GALP), and Good Clinical Practice (GCP), and regulations such as Good Manufacturing Practice (GMPs) and quality system regulation have been issued steadily over the past several years. The objective of the validation process is to ensure that a system does what it purports to do and will continue to do so. Validation not only satisfies regulatory requirements but also is a good tool for organizations to use so that they can feel confident that the LIMS performs the way they expect it to.