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Chapter
- HISTORY
- INTRODUCTION OF 21 CFR , PART 11
- SCOPE
- REGULATORY REQUIREMENTS
- DEFINITIONS
- PROCEDURE
- GENERAL REQUIREMENTS OF ELECTRONIC RECORDS
- GENERAL REQUIREMENTS OF ELECTRONIC SIGNATURE
- ELECTRONIC SIGNATURE COMPONENTS AND CONTROLS
- KEY POINTS OF 21 CFR , PART 11
- INSTRUCTION FOR EVALUATION
- EVALUATION QUESTIONNAIRE
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DEFINITIONS