Managing the Documentation Maze: Answers to Questions You Didn't Even Know to Ask

GUIDANCE FOR INDUSTRY: Part 11, Electronic Records; Electronic Signatures—Scope and Application

Division of Drug Information, HFD-240Center for Drug Evaluation and Research (CDER)(Tel) 301-827-4573http://www.fda.gov/cder/guidance/index.htmorOffice of Communication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and Research (CBER)http://www.fda.gov/cber/guidelines.htmPhone: the Voice Information System at 800-835-4709 or 301-827-1800

or

Communications Staff (HFV-12),Center for Veterinary Medicine (CVM)(Tel) 301-594-1755 http://www.fda.gov/cvm/guidance/guidance.html

or

Division of Small Manufacturers Assistance (HFZ-220)http://www.fda.gov/cdrh/ggpmain.htmlManufacturers Assistance Phone Number: 800.638.2041 or 301.443.6597Internt'l Staff Phone: [phone]

or

Center for Food Safety and Applied Nutrition (CFSAN)http://www.cfsan.fda.gov/~dms/guidance.html.

U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)Center for Devices and Radiological Health (CDRH)Center for Food Safety and Applied Nutrition (CFSAN)Center for Veterinary Medicine (CVM)Office of Regulatory Affairs (ORA)

August 2003Pharmaceutical CGMPs