[CITE:21CFR11] 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 Sec. 11.1Scope. ...
联邦法规:21CFR Part11“电子数据电子签名审计追踪” 中英对照 . 21 CFR Part 11 21cfr part 123 美国水产品 hacc 美国良好规范21CFR part 73 译文==讲解 可见分光数据符合21CFR 第11部分的要求 美国《低酸罐头食品法规》21CFR Part 113 FDA GMP 21CFR PART110 介绍及应用 相关搜索 美国联邦法典 cfr联邦...
How do Microsoft enterprise cloud services demonstrate compliance with FDA CFR Title 21 Part 11?Using the formal audits prepared by third parties for SOC 1 Type 2, SOC 2 Type 2, ISO/IEC 27001, and ISO/IEC 27018, Microsoft is able to show how relevant controls noted within these reports ...
XRDynamic 500 拥有着高灵活性,高自动化程度,以及更好的数据质量,它将是您进行 X 射线衍射的最佳选择。软件现满足 21 CFR Part 11 的要求,确保了数据的可追溯性。
美国医疗器械法规CFR-2021-title21-vol8-part812.docx,Food and Drug Administration, HHS § 812.1 agency determines that such notifica- tion may cause unnecessary and harm- ful anxiety in individuals and that ini- tial consultation between individuals and th
FDA 医疗器械法规 CFR-2021-title21-vol8-part801.pdf,Pt. 801 21 CFR Ch. I (4–1–21 Edition) (iii) of this section, FDA will render a PART 801—LABELING decision within 45 days of the request for supervisory review. Subpart A—General Labeling Provisions (
PharmaReady ™ FDA Compliant Document Management System Title 21 CFR Part 11 cross-reference 21 CFR Part 11 RequirementSolution, Pharmaready
FDA 医疗器械法规 CFR-2021-title21-vol8-part860 下载积分: 1000 内容提示: 197 Food and Drug Administration, HHS §860.3 PART 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES Subpart A—General Sec. 860.1 Scope. 860.3 Definitions. 860.5 Confidentiality and use of data and in-formation submitted in ...
美国医疗器械法规CFR-2021-title21-vol8-part807.docx,Food and Drug Administration, HHS Pt. 807 device. Records required to be main- tained under paragraph (b) of this sec- tion must be transferred to the new manufacturer or importer of the device and maint
FDA 医疗器械法规 CFR-2021-title21-vol8-part860.pdf,Food and Drug Administration, HHS § 860.3 PART 860—MEDICAL DEVICE sification of devices intended for CLASSIFICATION PROCEDURES human use. (b) This part prescribes the criteria Subpart A—General and pr