PART 11Electronic Records; Electronic Signatures 第11款 电子记录;电子签名 Subpart A--General Provisions 分章A 一般规定 Sec. 11.1 Scope. 11.1适用范围 (a)The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten ...
PART 11Electronic Records; Electronic Signatures 第11款 电子记录;电子签名 Subpart A--General Provisions 分章A 一般规定 Sec. 11.1 Scope. 11.1适用范围 (a)The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten si...
PART 11-ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 第 11 款 电子记录;电子签名 Subpart A —General Provisions 分章 A —— 一般规定 11.1 Scope. 11.1 适用范围 11.2 Implementation. 11.2 履行 11.3 Definitions. 11.3 定义 Subpart B—Electronic Records 分章 B —— 电子记录 11.10 Controls for closed ...
本文由公众号AnalyticalLab 整理翻译，仅供交流，切勿作为行动依据！ 21 CFR Part 11 LIMS Requirements Electronic signatures and records 21 CFR Part 11 中关于LIMS 对电子签名和记录的要求 1. Electronic Signatures 电子签名 UR-1: Electronic signatures must be unique to each individual. Each user must ...
第11款 电子记录;电子签名 Subpart A--General Provisions 分章A一般规定 Sec. 11.1 Scope. 11.1适用范围 (a)The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be tru...
PART 11 Electronic Records; Electronic Signatures第 11 款 电子记录;电子签名Subpart AGeneral Provisions分章 A 一般规定Sec. 11.1 Scope.11.
PART11 ElectronicRecords;ElectronicSignatures 第11款 电子记录;电子签名 SubpartA-—GeneralProvisions 分章A一般规定 Sec. 11.1Scope。 11。1适用范围 (a) The regulationsinthispartset forth the criteriaunder whichtheagencyconsiders electronicrecords,electronic signatures, andhandwrittensignaturesexecutedto electron...
联邦法规:21CFRPart11“电子数据,电子签名,审计追踪”中英对照.pdf,PART 11 Electronic Records; Electronic Signatures 第11 款 电子记录;电子签名 Subpart A--General Provisions 分章A 一般规定 Sec. 11.1 Scope. 11.1 适用范围 (a) The regulations in this part set
电子签名(Electronic Signatures) 电子签名应具有三个特性:唯一性,确定性和合法性。唯一性是指个人拥有的电子签名应该是一一配对的,唯一的,(即使此人今后不再使用其电子签名),该电子签名也不能被他人再次使用,或被再次分配给其他人。确定性是指当组织创建、分配、认证、批准个人的电子签名(或电子签名的要素)之前,组...
PART 11Electronic Records; Electronic Signatures 第11款 电子记录;电子签名 Subpart A--General Provisions 分章A一般规定 Sec. 11.1 Scope. 11.1适用范围 (a)The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten ...