Regulation analysis: What is -FDA-21-CFR-Part-11?
Regulation analysis: What is FDA 21 CFR Part 11? US FDA promulgated 21 CFRPART 11 in 1997, and enacted relevant industry guidelines in 2003 to refine the relevant rules. In Part11, electronic records are considered to have equivalents with written records and handwritten signatures. 21CFRPART 11 is widely accepted by t……
Time：2017-11-23 [ Support ]
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