VALIDATION OF THE LABORATORY INFORMATION-SYSTEM

Objective.-To present an organized and practical approach to the valid ation of laboratory information systems. Sources.-Personal experience, published papers, technical manuals, and Food and Drug Administration guidelines. Data.-Validation of the laboratory information system is the continuing process of proving the system fit for its intended use, initially and over time. It consists in defining, collecting, maintai ning, and independently reviewing evidence that the system will perfor m consistently according to specification. Validation is tedious, diff icult, and costly, but it must be done to assure that the system is fi t for use and is working according to specification. In addition to pr ofessional and licensing bodies, laboratories making blood products fa ll under the regulatory requirements of the Food and Drug Administrati on. The buyer of a system is responsible for verifying that the develo per has complied with all regulations and that the software products a re validated to an appropriate degree, that the hardware is certified to perform its designated functions, that an appropriate period of acc eptance testing has been done and documented, and that the system in u se performs to specification and is under control. Conclusion.-System validation demonstrates to all concerned, inside and outside the labor atory, that the laboratory information system manages information well , with the expected accuracy and reliability, file integrity, auditabi lity, and management control.