A globally harmonized glossary of terms for communicating computer validation key practices.

In the pharmaceutical, medical device, biotech, and blood bank industries, a computer validation vocabulary has emerged over time from many different sources. These sources include industry group publications, regulatory agency guidance documents, terminology from the computer industry, and articles written by individuals. Since these efforts were not harmonized, several independent glossaries exist today. Because these glossaries sometimes differ or contradict each other, terminology has proven to be a source of confusion. This article establishes a common global, harmonized glossary of terms required to understand and communicate computer validation key practices.