The use of computer systems and computerized devices in the laboratory is becoming nearly universal, and increasingly processes once performed by people are being transferred to machines, the inner workings of which may be only dimly understood. The task of the people managing the work of the laboratory is to comprehend the processes by which the computerized labora­ tory information system (LIS) in use, usually acquired as a package from a vendor, may be shown to be doing the job it is expected to do. The functions of the system must be validated. Useful discussions of regulation! and inspec­ tion and accreditation2 of laboratory information systems are available. How­ ever, despite its importance there is remarkably little published outside the blood bank literature about the validation of laboratory information systems that is accessible to general users of the systems, that is, addresses specifi­ cally laboratory issues in terms and concepts familiar to the laboratorian. Our intention here is to discuss LIS validation as it applies in the laboratory in general, to define the issues related to validation, and to suggest an approach to dealing with them. Validation of the laboratory information system is the continuing process of proving the system fit for its intended use, initially and over time. Valida­ tion consists of defining, collecting, maintaining, and independently review­ ing evidence that the system is consistently performing according to specifications. This is no small task, as many parts of a vendor-supplied LIS are proprietary, and some are so complex as to be beyond the ability of a user to evaluate in detail. Validation is resource intensive, and while certain as­ pects of validation testing are increasingly done with the support of auto­ mated utility programs, it remains a mainly manual operation involving many work hours. Difficult or not, this task must be undertaken, because it is an essential component of a quality management system, and the laboratory has a legal and ethical responsibility to assure itself and its clients that data

3 of the Laboratory Information System

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3 of the Laboratory Information System