Watch and Learn : 21 CFR Part 11 Regulations
This article is meant to provide a very high level overview of the key elements of 21 CFR Part 11 regulations from the Food and Drug Administration. It delves into the following topics:
1. Introduction to 21 CFR Part 11 regulations
2. Key elements of 21 CFR Part 11
• Electronic Records : Definition of Electronic Records
• Electronic Signatures: Definition of Electronic Signatures
• Audit Trails: Definition of Audit Trails, ALCOA definition, basics of what goes into an audit trail.
3. Deeper dive into Subpart B: Electronic Records
• Subpart B: 11.10 and 11.20 - Controls for Closed and Open systems
• Subpart 11.50: Signature Manifestations
• Subpart 11.70...