Part 11 SoftwareCPR Memory Jogger$

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A one page memory jogger for key sections of the Part 11 rule is at the link provided.  This is a SoftwareCPR training and auditing aide. This was updated Feb 2003 to highlight items for which FDA is changing its approach and reducing the burden of this rule as part of a modernization effort. A draft guidance document on Scope and Application is available . . .

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