Mastering 21 CFR Part 11 Compliance: A Comprehensive Guide for Clinical Trials in the Digital Age
Cloudbyz
JUNE 10, 2023
Understand the Scope: First and foremost, understand the electronic systems you use and determine which records are subject to 21 CFR Part 11. Implement Secure Systems: Invest in software and hardware systems that provide secure access control, audit trail capabilities, and electronic signature features.
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