With the U.S. Food and Drug Administration making it clear in recent guidance that electronic regulatory records in site-owned systems are definitely subject to CFR 21 Part 11 in the Code of Federal Regulations, this session focuses on how sites need to understand the requirements and develop strategies for compliance.
CEU: 1.00 ACRP
Speaker:
Stuart Cotter, VP, Product Strategy, Advarra
Related Blog Content:
Understanding a Site’s Responsibilities for Essential Documents in Electronic Systems