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 ...
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 have a unique Full Name. Each user must have a unique user i...
内容提示: Guidance for Industry Part 11, Electronic Records; Electronic Signatures August 2003Page 1 of 13Guidance for IndustryPart 11, Electronic Records; Electronic Signatures— Scope andApplicationAugust 2003Pharmaceutical CGMPsFDA 工业指南联邦法规 11 分 部分 电子记录和电子签名— 范围和应用2003 年 8...
guidance for industry part 11electronic records;electronic signatures -scope and application 热度: FDA 21 CFR Part 11电子记录和签名:生命科学产业的解决方案Electronic records and signatures – solutions for the Life Sciences Industry-ABB 热度:
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...
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...
Title 21 → Chapter I → Subchapter A → Part11 TITLE 21 — Food and Drugs 食品和药品 CHAPTER I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES 食品药品管理局,卫生福利部 SUBCHAPTER A — GENERAL 通则 PART 11 — ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 电子记录,电子签名...
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTHAND HUMAN SERVICES食品药品管理局,卫生福利部 SUBCHAPTER A—GENERAL通则 PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES电子记录,电子签名 Sec. 11.1 Scope.范围 (a)The regulations in this part set forth the criteria under which the agency co...
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 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 ...