A review of autovalidation software in laboratory medicine

Although autovalidation procedures have been around for many years, through the use of computers and the application of (medical) protocols, they are now becoming part of the production environment of medical laboratories. The introduction of high volume instruments within routine medical laboratory testing certainly speeded up their application as well. After defining autovalidation, autoverification and autoconfirmation, this paper provides a framework for the different ways and places where these tools can be applied within laboratory medicine. Technology as well as organization are essential building blocks to reach well-defined, transparent and assured quality. A laboratory automation system (LAS) brings both areas together in a logical, future-oriented way. Strengthening the information loop, reaching guaran-teed quality (analytical, turnaround times and efficiency), leads towards strict management of the laboratory processes. This includes all laboratory processes and here autovalidation and autoreporting become essential. A survey of currently available software routines and their appraisal from a managerial viewpoint are given. It can be concluded that autovalidation software in laboratory medicine is maturing and is rapidly becoming a critical success factor in any medical laboratory. Quality can be automated for sure and autovalidation software will prove to be a valuable aid to do so.