A review of us EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions

摘要

Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that Address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data Interchange (EDI) guidelines: 1) the EPA electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.Epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also Available at: www.ega.gov/oppeedi1/edipoli.htm.