UCI Health EPIC and 21 CFR Part 11 Compliance

Dear Researchers,

UCI Health researchers involved with FDA-regulated studies may be asked to certify compliance with 21 CFR Part 11 regulations for the development, implementation, and use of electronic records and signatures. Information Security has provided a Statement on UCI Health EPIC EHR System Compliance with 21 CFR Part 11 (attached).

The attached statement is also available on the UCI Health Intranet under ‘Clinical Tools > Policies/Compliance’.  You may also contact Research Compliance for a copy (researchcompliance@hs.uci.edu).

Thank you.

UCI Health – Compliance & Privacy Office