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Saturday, 26 July 2008
 
 

Common Sense Change Control in Regulated Life Science Environments

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Common Sense Change Control in Regulated Life Science Environments

Sometimes it seems like regulatory agencies (FDA, ISO, etc.) are too controlling. When it comes to change control processes however, regulatory agencies often say very little. Why is it then that change control related 483s issued by the FDA continue to be distributed at such prolific rates?
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