$Compliance Training templates for Software$

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The attached zip file contains 3 training templates. One is for an example software development SOP, one is a companion software development plan, and one is a template for software risk analysis incorporating the concept of predefined categories of Risk Control Effectiveness (RCE). These contain significant explanatory commentary. They are intended as training examples and not as a one size fits all approach. While . . .

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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