A PRACTICAL APPROACH TO AUDITING LIMS IN LABORATORIES INVOLVED WITH ISO QUALITY ASSURANCE SYSTEMS

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 validat ion are covered. The LIMS example considered here is implemented in a laboratory subject to quality assurance programs. The discussions cove r several topics to accomplish with ISO 9000 requirements for validati on and software requirements (as well as with the more recent updating of the ISO 25 Guide, focused especially on testing laboratories). Spe cial emphasis is placed on responsibilities of laboratory and informat ion department staff. This paper discusses the responsibilities and ta sks to be assumed by laboratory managers throughout the LIMS life cycl e; from the first senior management decisions to the first global vali dation. Several errors that can arise in networking environments are d iscussed. The influence of a LIMS implementation on the laboratory mod us operandi as well as personnel attitudes and training topics are cov ered.