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September 1, 2002
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. The document at the link provided is a SoftwareCPR training aid that provides a partial template with some tips for construction of a handbook/procedure that addresses IT/Network issues regulatory compliance with 21 CFR Part 11 requirements and to support...
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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