Herr R R, Wyrick M L
Pharmacia & Upjohn, Kalamazoo, Michigan, USA.
PDA J Pharm Sci Technol. 1999 Mar-Apr;53(2):97-103.
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.
在制药、医疗器械、生物技术和血库行业，随着时间的推移，计算机验证词汇已从许多不同来源应运而生。这些来源包括行业组织出版物、监管机构指导文件、计算机行业术语以及个人撰写的文章。由于这些工作未得到统一协调，如今存在几个独立的术语表。由于这些术语表有时存在差异或相互矛盾，术语已被证明是造成混淆的一个根源。本文建立了一个通用的全球统一术语表，用于理解和交流计算机验证的关键实践。
