The European Medicines Agency (EMA) has released a new draft guideline on process validation that brings EMA thinking in line with the International Conference on Harmonization of Technical ...
Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
This article overviews some of the benefits and methods of state-based control as it applies to the models defined by the ISA106, Procedure Automation for Continuous Process Operations standards ...
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