The Association of Clinical Research Professionals

Strategies for Ensuring Part 11 Compliance at Research Sites

With the proliferation of electronic regulatory document management systems in clinical research, investigative sites are at risk of compliance findings if they do not have strategies in place to ensure sites comply with 21 CFR 11 regulations. Learn the various aspects and best practice for helping sites build an appropriate risk based approach to Part 11 compliance for their electronic records. Speakers will explore tools to help sites understand their commitments and document their compliance with the appropriate regulation.


This program is a recorded session from ACRP 2018