21 CFR Part 11 Compliance

We Do Not Recommend SC CTSI REDCap for studies requiring Part 11 Compliance.

What is 21 CFR Part 11?

Part 11 of the Title 21 Code of FDA’s Federal Regulations describes requirements for electronic records, electronic signatures, and handwritten signatures applied to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper.

Is REDCap Part 11 Compliant?

REDCap has the technical features and capacities necessary to serve as an environment for a Part 11 compliant study. However, if the study requires compliance, the research team is responsible for validating their project. An FDA auditor will review for PROJECT LEVEL compliance.

SC-CTSI will not be undertaking the process to validate and maintain system-level Part 11 compliance for the USC instance of REDCap.

More information on Part 11 requirements can be found on the FDA website here. Steps for project-level validation can be found here.