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May 27, 2007
This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. Our SoftwareCPR audit checklist for assessing conformance with the FDA Guidance for "Computerized Systems Used in Clinical Trials" can be viewed and downloaded at this link:  ClinicalTrialsSWFullChecklist. This checklist has been updated by Mary Decareau of SoftwareCPR to reflect...
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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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