#Final draft 7 system requirements code#
This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations Electronic Records Electronic Signatures (21 CFR Part 11). If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Guidance for Industry 1 Part 11, Electronic Records Electronic Signatures. Approach to Specific Part 11 Requirements.Overall Approach to Part 11 Requirements.Manufacturers Assistance Phone Number: 80 or 30Ĭenter for Food Safety and Applied Nutrition (CFSAN)
Phone: the Voice Information System at 80 or 30ĭivision of Small Manufacturers, International, and Consumer Assistance (HFZ-220) Center for Biologics Evaluation and ResearchĬenter for Drug Evaluation and Research (CDER)Ĭenter for Biologics Evaluation and Research (CBER)
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