21 CFR 11, 210/211, 820 and ICHQ7 with Audit Checklists - GMP Auditor’s Basic Handbook

US FDA Title 21 CFR Parts

• Part 11 - Electronic Records/Electronic Signatures (ERES)
• Part 210/211 - cGMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals
• Part 820 - Quality Management System Regulations (QMSR) 2026

International Council of Harmonization  ICH Q7

Auditor's Check Lists & ICH Q7

• Part 11 Electronic Systems Auditor's Checklist
• Pharmaceutical GMP Auditor's Checklist
• The Auditing Group's 21 CFR Part 820 QMSR Audit Check List with correlations to 21 CFR Part 820, ISO 13485
• ICH Q7 API Auditor's Checklist                                                                                                

  Note:

  Does not include ISO 13485, however, does include the checklist correlations to 820 QMSR.