最新-21-CFR-PART-11-企业指南---中英对照
13页1、Guidance for Industry Part 11 Electronic Records Electronic SignaturesAugust 2003 Page 1 of 13 Guidance for Industry Part 11 Electronic Records Electronic Signatures Scope andApplication August 2003 Pharmaceutical CGMPs FDA 工业指南工业指南 联邦法规联邦法规 11 部分部分 电子记录和电子签名电子记录和电子签名 范围和应用范围和应用 2003 年 8 月 药物 CGMPs TABLE OF CONTENTS目录目录 I Introduction 2 II Background 3 III Discussion 5 A OverallApproach to Part 11 Requirements 5 B Details ofApproach Scope of Part 11 6 1 Narrow Interpretation of Scope 6 2 Definit
2、ion of Part 11 Records 7 C Approach to Specific Part 11 Requirements 9 1 Validation 9 2 Audit Trail 9 3 Legacy Systems 10 4 Copies of Records 11 5 Record Retention 12 IV REFERENCES 13 Guidance for Industry Part 11 Electronic Records Electronic SignaturesAugust 2003 Page 2 of 13 This guidance represents the Food and Drug Administration s FDA s current thinking on this topic It does not create or confer any rights for or on any person and does not operate to bind FDAor the public You can use an al
3、ternative approach if the approach satisfies the requirements of the applicable statutes and regulations If you want to discuss an alternative approach contact the FDA staff responsible for implementing this guidance If you cannot identify the appropriate FDA staff call the appropriate number listed on the title page of this guidance I Introduction This guidance is intended to describe the Food and Drug Administration s FDA s current thinking regarding the scope and application of part 11 of Tit
4、le 21 of the Code of Federal Regulations Electronic Records Electronic Signatures 21 CFR Part 11 This document provides guidance to persons who in fulfillment of a requirement in a statute or another part of FDA s regulations to maintain records or submit information to FDA have chosen to maintain the records or submit designated information electronically and as a result have become subject to part 11 Part 11 applies to records in electronic form that are created modified maintained archived re
5、trieved or transmitted under any records requirements set forth in Agency regulations Part 11 also applies to electronic records submitted to the Agency under the Federal Food Drug and Cosmetic Act theAct and the Public Health Service Act the PHSAct even if such records are not specifically identified inAgency regulations 11 1 The underlying requirements set forth in theAct PHSAct and FDA regulations other than part 11 are referred to in this guidance document as predicate rules As an outgrowth
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