Attached are slides of a presentation by FDA’s Device Center’s Software Compliance Expert John Murray. This was presented in April 2006. In addition to some explanations on the interrelationships of software validation and design control Mr. Murray emphasizes the need for “thinking”, focusing on the intent of the regulation, and articulating what you have done. On slide 13 he mentions the 3 A’s : activities, artifacts, and attributes as a key to compliance.
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