Talk:Computerized system validation

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)

→I agree with the first comment. While the FDA guidance refers to it as "Computerized", I've been doing it for 30 years and have never heard anyone refer to it as "Computerized". I updated the first paragraph to reflect that. I also added in the reference to this mostly being utilized at pharma and other FDA regulated companies, as well as more detail regarding the purpose of CSV, which is to allow the replacement of paper records with electronic records. Re 'process' versus 'methodology', I believe it is both, but 'process' is more accurate because it is a process, while the methodology can vary widely across companies and still be considered CSV. Wikiguy91311 (talk) 04:31, 10 September 2021 (UTC)