No. System Validation reports are completed as FDA CFR 21 Part 11 compliance. Wash U REDCap is not CFR 21 Part 11 certified and we are not currently completing any processes working towards making Wash U REDCap FDA CFR Part 11 certification. We may begin this process in the future but we currently are not working towards REDCap CFR 21 Part 11 certification. If you are beginning a study that requires CFR 21 Part 11 please do not use REDCap. If we do begin to work towards certification, it would be a minimum of two years from the start date before completed.
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