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January 25, 2003
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR suggestions for a validation or Part 11 master plan are that it be a high-level plan not providing detailed document or protocol formats. Generally it is best if a master plan is a transient document.  It gets constructed...
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ADVAMED provided a white paper to FDA as part of the Part 11 Industry Coalition. This paper proposes that health and safety risk be used to properly interpret and apply Part 11 and that this approach would resolve some of industry’s issues rather than an approach focused on fraud. ADVAMED BLiebler Part11 Risk Paper
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