FDA 21CFR 11和欧盟附件11指南皮书.pdfVIP

相同部分 Annex11 附件11 21CFR Part11 21cfr 第11 部分 Section Description 描述 Section Description 第二节 第二节 描述 Principle Scope:范围 11.1(b) • Applies to records in electronic form that are req 原则 • Applies to all forms of computerized systems as 11.1(e) uiredby predicate brule.适用于由谓词规则所要求的电子 part of GMP regulated activities.适用于所有形式的计 形式的记录 算机系统，作为gmp 规范中的一部分。 • Computer systems,controls,and documentation 坛 Shall be available for FDA inspection.计算机系统、控 制和文件应可供fda 检查 Validation :验证 11.10(a) Validation of systems 系统的验证 •Application should be validated 应用程序应予以 论 验证 • IT infrastructure should be qualified.信息技术 的基础设施应该是合格的 术 Computerized systems can replace manual op 11.1(a) •Electronic records,electronic signatures,and erations:计算机系统可以取代手工操作： 11.2(a) handwritten signatures executed to electronic •No resultant decrease in product quality, 11.2(b) records are reliable and equivalent to paper Process control or quality assurance 产品质量、 records and handwritten signat