Critical thinking is the foundation of Computer System Assurance (CSA). The content in this eBook, sponsored by Sparta Systems, represents Axendia’s analysis and insights on FDA’s anticipated Draft Guidance: Computer Software for Manufacturing, Operations, and Quality Systems Software.
Our recommendations are based on the following trusted sources: Axendia’s integration with FDA representatives on this topic, content & material sourced from FDA, and first-hand experience from Axendia’s client’s implementation of CSA.
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