Japanese–English glossary
System suitability
システム適合性shisutemu tekigōsei
Checks made each time an analytical system is used, before or during a run, to confirm that the instrument, column, reagents and procedure work adequately that day; for chromatography, typically resolution, repeatability, tailing and plate count. It does not replace method validation, which shows the method can work; system suitability shows it is working in the current run. Japanese Pharmacopoeia methods and the test methods in Japanese approvals state system suitability criteria. A failed system suitability invalidates the run instead of producing an out-of-specification result.