FDA工业指南：联邦法规11部分电子记录和电子签名 —范围和应用.pdf

Guidance for Industry Part 11, Electronic Records;Electronic Signatures — Scope and Applicat ion August 2003 Pharmaceutical CGMPs FDA 工业指南 联邦法规11 部分电子记录和电子签名 — 范围和应用 2003 年8 月 药物CGMPs This guidance represents the Food and DrugAdministrations (FDAs) current thinking on this topic. It does not createor confer any rights for or on any person and does not operat e to bind FDA orthe public. You can use an alternative approach if the approach satisfies therequirements of the applicable statutes and regulations. If you want todiscuss an alter native approach, contact the FDA staff responsible forimplementing this guidance. If you cannot identify the appropriate FDA staff,call the appropriate number listed on the title pa ge of this guidance. 本指南代表了FDA 在此领域的当前思路，它不赋予任何人任何权利，也并非用于约束FDA 或公众。您还可以选择使用另一种符合要求和法规的替代方法。对替代方法有任何问题， 请与负责实施本指南的相关人员联系；如果您无法确认联系人，可拨打本指南首页中相应 的电话号码咨询。 1.Introduction 1.介绍 This guidance is intended to describe the Food andDrug Administrations (FDA’s) current thinking regarding the scope andapplication of part 11 of Title 21 of the Code of Federal Regulations;Electronic Records; Electronic Signatures (21 CFR Part 11). 该指南旨在给出FDA 21 CFR 第11 条：电子记录、电子签名的当前思路。 This document provides guidance to persons who, infulfillment of a requirement in a statu te or another part of FDAsregulations to maintain records or submit information to FDA, h ave chosen tomaintain the records or submit designated information electronically and, a sa result, have become subject to part 11. Part 11 applies to records inelectronic form tha t are created, modified, maintained, archived, retrieved,or transmitted under any records r equirements set forth