When it comes to verification and validation, medical device companies need to ensure that what they're doing actually makes sense. Known colloquially as "V&V," for many it feels like you're on the ...
The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation. The regulatory basis for process validation is ...
This article considers the distinction among the terms qualification, validation, and verification in the context of pharmacopeial usage.A recommendation for a standardized usage of the terms ...
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