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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 the new version from FDA released May 2007 . The checklist focuses on computer system and software, not on study site procedural requirements or study protocol requirements. The guidance includes significant information related to 21 CFR Part 11 for Electronic Records and Signatures and some of this information is included in this checklist. This guidance has useful information beyond clinical trials system and is informative for general production and quality system support systems.