The US Food and Drug Administration (FDA) has issued a draft guidance entitled ‘Computer Software Assurance for Production and Quality Management System Software’. Aimed at medical device manufacturers - check this out and other recent regulatory updates: https://www.rssl.com/insights/life-science-pharmaceuticals/issue-42-pharmaceutical-regulatory-roundup/
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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