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ICH E6 (R3) Good Clinical Practice - Updated 2025
Part 11 - Scope & Application August 2003
Part 600 - Biological Products: General
US FDA Title 21 CFR Part 11 Electronic Records
Part 803 - Medical Device Reporting
21 CFR 11, 110, and 117 - Electronic Records with Food GMPs ICH E6 (R3) Good ClinicalUS FDA Title 21 CFR Parts Part 11 Electronic Records Electronic Signatures (ERES) Part 110 Current Good Manufacturing Practice in Manufacturing, Packaging or Holding Human Food Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food
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