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The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part 11 affected, a side by side of the Draft Scope and Application guidance with SoftwareCPR explanation and comments, and the federal register notice withdrawing all prior FDA Part 11 guidances and its Compliance Policy guide and explaining the new approach.
We hope this is helpful. Note that Part 11 interpretation and enforcement continue to evolve.