21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs Part 50 Protection of human

Part 50 Protection of human subjects

Part 58 - Good Laboratory Practice

and complaint handling

Electronic Records and Good Laboratory Practice

Checklist for Computerized Systems and Part 11

21 CFR 11, 58, 210/211, 600, 601, 610, 820 - Multi-US GMPs Part 50 Protection of humanMulti US GMPs US FDA Title 21 CFR Parts: Part 11 Electronic Records Electronic Signatures (ERES) with Scope and Application Part 58 Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies Part 210 211 GMP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals Part 600 Biological Products: General Part 601 Licensing Biologics Part 610 General Biological Products Standards Part 820 Quality Management System