This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions.

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 . . .

Thank you for your interest!  To view our Premium or Standards Navigator content, please click here to select the plan that best fits your needs.