This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. 21 CFR Part 11 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.