Validation of the laboratory information system.
OBJECTIVE
To present an organized and practical approach to the validation of laboratory information systems.


METHODS
Personal experience, published papers, technical manuals, and Food and Drug Administration guidelines.


METHODS
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, maintaining, and independently reviewing evidence that the system will perform consistently according to specification. Validation is tedious, difficult, and costly, but it must be done to assure that the system is fit for use and is working according to specification. In addition to professional and licensing bodies, laboratories making blood products fall under the regulatory requirements of the Food and Drug Administration. The buyer of a system is responsible for verifying that the developer has complied with all regulations and that the software products are validated to an appropriate degree, that the hardware is certified to perform its designated functions, that an appropriate period of acceptance testing has been done and documented, and that the system in use performs to specification and is under control.


CONCLUSIONS
System validation demonstrates to all concerned, inside and outside the laboratory, that the laboratory information system manages information well, with the expected accuracy and reliability, file integrity, auditability, and management control.
Cowan
D F
DF
Department of Pathology, University of Texas Medical Branch, Galveston 77555-0555, USA.
Gray
R Z
RZ
Campbell
B
B
D002984:Clinical Laboratory Information Systems / Q000295:instrumentation / Q000592:standards*; D003201:Computers / Q000592:standards; D005069:Evaluation Studies as Topic; D006801:Humans; D011785:Quality Assurance, Health Care; D012984:Software / Q000592:standards