Day

September 4, 2000
04
Sep

Part 11 Side by Side Preamble and Rule$

September 4, 2000,
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. 21 CFR Part 11 Electronic Records and Electronic Signatures is a short rule with a lengthy and informative preamble.  The attached training aid provides section of the rule side by side with relevant excerpts of the preamble with some...
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04
Sep

Part 11 SoftwareCPR Explanation and Commentary$

September 4, 2000,
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The attached document is a SoftwareCPR training aid with commentary and explanation of 21 CFR Part 11 Electronic Records; Electronic Signatures by SoftwareCPR.  Note the date of this document as this is an evolving area. erecordsesigscommentary09012000-346
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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  June 2-4, 2020
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