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21 CFR 11, 110, 111 and 117 - Food and Dietary Supplement GMPs Part 11 Scope and Application

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Description

Part 11 Scope and Application August 2003

Part 11 Electronic Records

ICH E8 (R1) General Considerations for Clinical Studies

the design

11 - Electronic Records

21 CFR 11, 110, 111 and 117 - Food and Dietary Supplement GMPs Part 11 Scope and ApplicationUS FDA Title 21 CFR Parts Part 11 Electronic Records Electronic Signatures (ERES) Part 110 CGMP in Manufacturing, Packaging or Holding Human Food Part 111 CGMP in Manufacturing, Packaging, Labeling, or Holding operations for Dietary Supplements Part 117 CGMP, Hazard Analysis, and Risk Based Preventive Controls for Human Food

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