21 CFR 11, 210/211, 820 QMSR - Electronic Records with Drug and Device GMPs

US FDA Title 21 CFR PARTS 11, 210/211 and 820 QMSR Standard GMP Pocket Guide

3 popular regulations in an easy to carry pocket handbook.

• US FDA Title 21 CFR Part 11 Electronic Records; Electronic Signatures with Scope and Application - August 2003
• 21 CFR Parts 210/211 Drug GMPs
• 21 CFR Part 820 - Quality Management System Regulations (QMSR) 2026 with ISO 13485 Reference Table

This regulation pertains to electronic records, electronic signatures and handwritten signatures executed to electronic records. This part also applies to records in electronic form that are created, modified, maintained, archived, retrieved or transmitted, under any records requirements set forth in agency regulations.