FDA Responds to Petition to Withdraw Part 11

In September of 2004 an Industry Coalition on Part 11 submitted a citizen’s petition to formally request that FDA withdraw the Part 11 regulation. FDA responded Mar 15, 2005 saying they have been unable to reach a decision. The letter is at the link provided.

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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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