-Centralized Laboratory -Data Acquisition & Reporting -Remote Data Entry -Case Report Form Systems -Clinical Data management -Adverse Event Reporting -Clinical Supply Systems -Statistical Analysis Systems
系统验证
误区二
软件符合（compliant）21 CFR Part 11
体系的符合性，除软件外，还包括体系内硬 件、SOPs、人员培训和管理的对21 CFR Part 11 的符合性。
21
CFR Part 11概述
21 21
CFR Part 11内容解读 CFR Part 11应用
CFR = Code of Federal Regulations 美国联邦法规21章第11款 电子记录和电子签名 /scripts/cdrh/cfdocs/ cfcfr/cfrsearch.cfm?cfrpart=11
概述
1997年8月20日颁布实施的法规 适用于包括现有体系内所有FDA监管的工 作中的电子记录 电子签名和电子记录的准则：可信的和可 靠的 电子签名 = 手写签名 最低要求 / 防止假冒

绪论 正文
从企业反馈中整理出来的问题解释

法规本身
目录
TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER A--GENERAL PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Subpart A--General Provisions § 11.1 - Scope. § 11.2 - Implementation. § 11.3 - Definitions. Subpart B--Electronic Records § 11.10 - Controls for closed systems. § 11.30 - Controls for open systems. § 11.50 - Signature manifestations. § 11.70 - Signature/record linking. Subpart C--Electronic Signatures § 11.100 - General requirements. § 11.200 - Electronic signature components and controls. § 11.300 - Controls for identification codes/passwords.
-Document Management -Quality Management -Computer Assisted NDA (CANDA)
*GISP- Good Information System Practices
注：引用自欧洲peri-workshop
误区一
21 CFR Part 11 认证
GCP
GMP
GISP *
-Data Acquisition -Laboratory Information Management (LIMS) -Laboratory Robotics -Toxicology Systems -Stability Systems -Environmental Impact

21 CFR




21CFR 21CFR58 21CFR210 21CFR211 21CFR312 21CFR314 21CFR6xx 21CFR820 21CFR…… 21CFR11
= Food and Drugs = GLP = GMP, Drugs (General) = GMP, Drugs (Finished Pharmaceuticals) = Inv. New drug Application (GCP) = FDA Approval of new drug (GCP) = GMP, biologics = GMP, Devices = Food, nutrients and cosmetics = Electronic Records; Electronic Signatures
为什么遵循21 CFR Part 11
FDA要求和应用 全球范围内的广泛推广 国内暂无相关法规或标准

《中华人民共和国电子签名法》2005年4月1日起施行

符合质量管理的要求
应用
GXP GLP
-GXP Training -GXP Tracking -SOP Systems
[ quality management systems ]
-Manufacturing Execution (MES) -Maintenance Management (MMS) -Calibration Management (MCS) -Facility Management Systems -Enterprise Resource Plan ( ERP) -SCADA Systems -Supply Chain Planning (SCP) -Internet Applications -EDI -PLC Systems
21 CFR Part 11 介绍
张 俊 2011.7
21
CFR Part 11概述
21
CFR Part 11内容解读 CFR Part 11应用
21
21
CFR Part 11概述
21 21
CFR Part 11内容解读 CFR Part 11应用
什么是21 CFR Part 11