Keatley K L
Colorado Analytical Research & Development, an Operating Unit of Pyxant Labs, Inc., Colorado Springs 80907, USA.
Qual Assur. 1999 Apr-Jun;7(2):77-89. doi: 10.1080/10529410050133844.
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.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, "Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, "Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway." The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, "Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999." This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, "FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997." This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.
美国环境保护局（EPA）和美国食品药品监督管理局（FDA）都发布了监管文件，阐述了向这两个机构进行电子报告的相关问题和要求。EPA发布了两份全面且实用的电子数据交换（EDI）指南：1）1994年9月23日和10月18日的《EPA电子数据交换（EDI）实施指南》草稿，可在EPA以下网站地址获取：www.epa.gov/oppeedi1/guidelines/general.pdf；2）1996年9月4日的《临时最终通知，通过电子数据交换提交电子报告》，《联邦公报》通知[FRL-5601-4，第61卷，第172期，第46684页]，也可在以下网址获取：www.epa.gov/oppeedi1/edipoli.htm。FDA发布了一份名为《行业指南，临床试验中使用的计算机化系统，1999年4月》的指南文件，可在FDA网站获取：www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm。FDA的指南文件涉及适用于GLP合规所有领域的电子记录的若干问题。FDA目前正在制定的另一份文件名为《监管信息传输电子标准（ESTRI）网关》。ESTRI文件定义了向FDA进行电子提交的战略计划。FDA在该领域发布了一份名为《行业指南：以电子格式提供监管提交文件——一般考虑因素，1999年1月》的指南文件。该指南文件可在以下网址获取：www.fda.gov/cder/guidance/index.htm。FDA还发布了一项适用于所有电子记录和签名的重要最终规则，该规则是美国联邦法规汇编（CFR）第21编第11部分的一部分，名为《FDA最终规则，电子记录；电子签名，1997年8月20日生效》。下面将讨论该FDA裁决，可在以下网址获取：www.fda.gov/cder/esig/index.htm。
