Japanese–English glossary
Computerized system validation (CSV)
コンピュータ化システムバリデーションkonpyūta-ka shisutemu baridēshon
Documented evidence that a computerized system used in GMP work, such as a laboratory data system, manufacturing execution system, electronic batch record or monitoring system, does what it is intended to do, consistently, throughout its lifecycle. In Japan the reference is the MHLW Guideline on Management of Computerized Systems for Marketing Authorization Holders and Manufacturers of Drugs and Quasi-drugs (PFSB/CND Notification No. 1021-11, October 21, 2010), issued with a Q&A the same day; English versions in circulation are unofficial translations. Japanese CSV packages commonly use GAMP 5 software categories and the V-model, with user requirements, functional specifications and IQ, OQ and PQ.