FDA Code of Federal Regulations 21CFR 11

21 Feb 2022

I have sent this inquiry elsewhere, but I thought I would contact RDA groups who are engaged specifically in issues of health data and research.
I had a discussion with the folks at the Office of Clinical Trials (OCT) here at the University of North Carolina at Chapel Hill, which is looking for solutions for compliance with the most recent version of the FDA Code of Federal Regulations - 21CFR11. From what the OCT described, they need to be able to organize and store study records, data, documentation, and other relevant research materials in a central archival system where FDA auditors can retrieve them for inspection purposes.
Of course, we all know of various repository platforms that can store, manage, and provide authorized access to study materials. But given that the OCT is responding to this specific 21CFR11 regulation, what are some other issues that need to be addressed when determining the most appropriate strategy for responding to FDA data audit requests under this regulation? I can think of issues related to human subjects research data management, and I see that the integrity and authenticity of electronic records is an important concern for the FDA, but what else does the Office of Clinical Trials need to address when establishing the tools and workflows to comply with this FDA regulation?
If you have any insight into this regulation and/or are working with your institution to establish mechanisms for 21CFR11 compliance, I would greatly appreciate it if you would share any information (e.g., systems, workflows, etc.) that would help inform the development of UNC’s strategy.
Thank you in advance,
Thu-Mai Lewis Christian (she/her/hers)
Assistant Director for Archives
H. W. Odum Institute for Research in Social Science
228E Davis Library, CB# 3355
University of North Carolina at Chapel Hill
Chapel Hill, NC 27599-3355
T: (919) 962-6293
F: (919) 962-2875