A practical approach to auditing LIMS in laboratories involved with ISO quality assurance systems

Abstract One of the greatest advances in industrial laboratories at present has been the implementation of laboratory information management systems (LIMS). In this paper the audit processes and schemes for LIMS validation are covered. The LIMS example considered here is implemented in a laboratory subject to quality assurance programs. The discussions cover several topics to accomplish with ISO 9000 requirements for validation and software requirements (as well as with the more recent updating of the ISO 25 Guide, focused especially on testing laboratories). Special emphasis is placed on responsibilities of laboratory and information department staff. This paper discusses the responsibilities and tasks to be assumed by laboratory managers throughout the LIMS life cycle; from the first senior management decisions to the first global validation. Several errors that can arise in networking environments are discussed. The influence of a LIMS implementation on the laboratory modus operandi as well as personnel attitudes and training topics are covered.