(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature. § 11.200 - Electronic signature components and controls. ...
联邦法规_21CFRPart11“电子数据,电子签名,审计追踪”中英对照-文档.docx,.. .. .. 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 i
fda21cfr 11部分本技术讨论了为满足说明.pdf,introduction Companies are facing many challenges in heavily regulated industries such as the Pharmaceutical, Medical devices, Cosmetic and Agro-food Industries. One important challenge is the validation of their
为什么要和我聊?你寂寞吗? You were big? Why has to chat with me? You lonely?[translate] aour validated software complies with CFR 21 part 11 certification standards for controlled access and archival storage 我们的被确认的软件遵照CFR 21第11部分证明标准为受控通入和档案库存储器[translate]...
Several companies from the pharmaceutical industry have recently asked for 21 CFR Part 11 certification for instrumentsnotconnected to a PC, just using the instruments' firmware. Please read why experts state, that standalone instruments cannot be 21 CFR Part 11 compliant and concepts offered in the...
47、 “地方运转办公室 ”( HFC-100, 5600 Fishers Lane, Rockville, MD 20857)并采用传统的手写签名(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signers handwr...
Use of Electronic Signatures implies that your system is an Electronic Record system and, therefore, must be in compliance with all provisions of 21 CFR Part 11. Do you have a format or example for the certification for e-signatures that a company can send to the FDA? For the exact ...
(e) Computer systems (includinghardware and software), controls, and attendant documentation maintained underthis part shall be readily available for, and subject to, FDA inspection. (f)本部分不适用于1.326-1.368章节确定所需要的记录。符合本章节第1部分J子部分要求的记录,如果在其他适用的法规约束下需要...
Persons using electronic signatures must, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature. Subsection 11.100(c.2) Electronic signatures that are not based upon biometrics must em...
21 CFR Part11对电子数据和电子签名提出了一些标准和依据,并列举了多种方式的管理,那么LabX是如何满足的呢?以下表格附带21 CFR Part11 原文(更新至2023.08.28)、翻译和解释,以及LabX实现方式和客户责任。 LabX 实验室管理软件www.mt.com/cn/zh/home/products/laboratory-software/labx-software.html?cmp=seo...