Original version: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf
U.S. Department of Health and Human Services
Food and Drug Administration (FDA)
Office of the Commissioner (OC)
May 2007
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System setup/installation (including the description and specific use of software, hardware, and physical environment and the relationship)
System operating manual
V alidation Validation and functionality testing
Data collection and handling (including data archiving, audit trails, and risk assessment)
System maintenance (including system decommissioning)
System security measures
Change control
Data backup, recovery, and contingency plans
Alternative recording methods (in the case of system unavailability)
Computer user training
Roles and responsibilities of sponsors, clinical sites and other parties with respect to the the use of computerized systems in the clinical trials