Expert system for precision testing in validation of liquid chromatographic methods

After a liquid chromatographic method has been developed, it must be validated to establish its limitations in daily use. Method validation is becoming increasingly important as stricter rules are applied by regulatory authorities. Precision testing is a vital step in this validation; both intralaboratory testing and interlaboratory testing are needed. In an intralaboratory test, repeatability and ruggedness tests are usually done. Expert systems are available for both tests. Here they are integrated to form an intralaboratory precision-testing expert system; special integration architecture is described. Important features of the integrated system are a supervisor containing planning knowledge about the tests and a common data structure containing all the objects necessary for an expert system in this area.