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During this discussion, we will try to comply the requirements of 21CFR Part 11, EU GMP annex 11 and approach by GAMP guide. This is a Series of Videos originally created for my students. Considering the fact that it can help all Computer System Validation VS Computer Software Assurance # This Discussion happened with Mr. Sachin Bhandari Sir, Who is responsible for IT compliances. He is supporting more than 40 ... Visit for more details on Computer Software Assurance. 0:17 - How did you measure the effectiveness of ... Software and systems are evolving, and so are the validation methods. There are better and modern ways to approach the old, ...
FDA guidance around computer software assurance ( The FDA's Case for Quality launched in 2011 stated that the initiative was set up to promote implementation of critical-to-quality ... What was the main impact of Computer System Assurance (
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