FDA's New Computer Software Assurance

 the FDA New, draft guidance on Computer Software Assurance (CSA) Guidance gains traction, more and more organizations are recognizing the value of a leaner approach and for those that have already implemented CSA, they're realizing it. Earlier this year I had a two-and-one-half hour discussion with a Validation Manager at a large pharmaceutical manufacturer, responsible for validation at over 50 global sites. Read more

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