Part 11 2/03 Changes & Guidance Training Aid$

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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 . . .

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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