Day

August 3, 2008
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed.  This example is modeled on the approach required by ISO 14971 and expands on it with...
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This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. This reference manual includes select FDA documents as well as SoftwareCPR training aides and checklists that SoftwareCPR uses in its training courses on Validation of Clinical Trials Computer Systems. The PDF is over 2 MB so be patient downloading...
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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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