The FDA requested system validation reports. Does Wash U REDCap have system validation reports?
- Christopher Sorensen
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.
The Trial-CARE Core Support Services studies offers a 3rd party installation of REDCapCloud that is CFR 21 Part 11 certified. Set up an initial consultation to learn more.
Please note, REDCapCloud is not related to the Wash U REDCap instance and Wash U REDCap Support does not provide free support for the REDCapCloud.