Ensuring Compliance with Part 11: A Site's Perspective
A PEER REVIEWED Article from Clinical Researcher
Written by: Cristina Ferrazzano Yaussy, MPH, CCRP, VP of Professional Services at Complion & James Wetzel, Senior Director at Oklahoma Heart Hospital
As more sites are looking to implement technology to go paperless, improve standardization, and provide secure access to essential documents, site staff ’s experience with ensuring compliance with 21 CFR 11 (Part 11) may be limited.
Balancing the need to maximize efficiency and ensure compliance presents a challenge, but with the right resources, the challenge is an achievable one.
Ensuring Compliance with Part 11: A Site's Perspective presents insight and expert advice from Cristina Ferrazzano Yaussy, MPH, CCRP and James Wetzel on how clinical research sites can maintain compliance with Part 11.
After reading this article, you'll learn:
- The critical components and site responsibilities related to Part 11
- Tips and best practices for developing and maintaining an effective compliance process
- The 6 Standard Operating Procedures (SOPs) your site should have in place to demonstrate compliance
- System or software functionality that is required for Part 11
- What sites need to know about selecting and auditing a vendor
- How recent ICG GCP E6 revisions affect validation and site responsibilities