15
May
2007

A Roadmap and Training Aid for Part 11$

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21 CFR Part 11 is a topic of current focus for FDA and industry. In February 2003 FDA announced a major change in direction regarding Part 11 and withdrew all previous draft Part 11 guidance and the Part 11 Compliance Policy guide. This indicates a significantly relaxed interpretation going forward and in a federal register announcement FDA made explicit its intent to intent to . . .

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