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)