2012 FDA Software Warning Letter Count

The total number of FDA software, computer system, and electronic records warning letters in 2012 is approximately 30 which is up from 18 in 2011 and fewer in 2009 and 2010. This is based on the keyword searches we perform on a regular basis but is not guaranteed to be comprehensive.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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