必威体育精装版 21 CFR Part 11 企业指南 - 中英对照.docxVIP

Guidance for IndustryPart 11, Electronic Records; Electronic Signatures — Scope and ApplicationAugust 2003Pharmaceutical CGMPsFDA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CGMPsTABLE OF CONTENTS目录I. Introduction2II. Background3III. Discussion5A. Overall Approach to Part 11 Requirements5B. Details of Approach - Scope of Part 1161. Narrow Interpretation of Scope62. Definition of Part 11 Records7C. Approach to Specific Part 11 Requirements91. Validation92. Audit Trail93. Legacy Systems104. Copies of Records115. Record Retention12IV. REFERENCES 13This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative 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. IntroductionThis guidance is intended to describe the Food and Drug Administrations (FDA’s) current thinking regarding the scope and application of part 11 of Title 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 FDAs 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, retrieved, 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 (the Act) and