Talk:Computerized system validation

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I believe that CSV actually stands for "Computer System Validation", and that it is a methodology rather than a process. The term "Computerized System Validation" suggests that validation is performed by a computer, which is not the case. It is a methodology to validate computer systems.

It might be good to point out that CSV is widely implemented at pharmaceutical companies.

Computerized Systems

This used to drive me crazy when I started working in the pharmaceutical industry, but no: the correct term is 'computerized,' because it's defined that way by the FDA (and other drug regulatory authorities.) See the FDA's glossary of software terms: http://www.fda.gov/iceci/inspections/inspectionguides/ucm074875.htm The reason is that, in this case, system refers to the business process, which embraces people, hardware, software, organizations (internal and external), etc. -- all governed by a company's Quality System. So, when computers were introduced into regulated environments beginning in the 1980s, it was said that the system was being 'computerized.' Monupics (talk) 16:28, 22 April 2015 (UTC)[reply]