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Introduction to FDA 21 CFR Part 11
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Introduction to FDA 21 CFR Part 11
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REGULATORY REQUIREMENTS
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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
10 questions