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 ...
FDA 21 CFR part 11译文 21 CFR Part 11是针对电子记录和电子签名的FDA法规，对于药厂和医疗器械使用的众多电子记录和电子签名提供了详尽的要求和规范。Subpart A--General Provisions A部分—通用规定 11.1 Scope.11.1 范围 (a) 本部分的法规制定了接受标准，用于机构评估电子记录、电子签名、电子记录加手写...
本文内容来自于《21CFRPart11LIMSRequirements-Electronicsignaturesandrecords》版权归原作者所有。本文由公众号AnalyticalLab整理翻译,仅供交流,切勿作为行动依据!UR-7:Electronicsignaturearenon-removable,non-modifiableandanintegralpartoftheelectronicrecords.UR-7:电子签名是固定的,不可修改的,是电子记录的组成部分。UR-...
11.50 Signature manifestations.签名表现形式 Subpart B—Electronic Records电子记录 11.70 Signature/record linking..签名/记录链接 Subpart C—Electronic Signatures电子签名 11.100 General requirements.一般要求 Subpart C—Electronic Signatures电子签名 11.200 Electronic signature components and controls.电子签名组件和...
have become subject to part 11. Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Fed...
Sec. 11.100 General requirements. 11.100一般要求 (a) Each electronic signature shall be unique to每一电子签名应是唯一对应单独(a) or reused by,一个人的并且不能被再使用、或再分配and shall not be one individual reassigned to, anyone else.给其他任何人。 (b) Before an organization establishes, ...
20, 1997, unI ess otherwise noted.备注:文中的“这部分内容”即指CFR Title21 Part 11。(a) Each electronic signature shaI I be unique to one indi vidua I and sha I I not be reused by, or reass i gned to, anyone e I se.(b) Before an organ i zat i on estab I i shes,ass i...
分章C 电子签名 Sec. 11.100 General requirements. 11.100一般要求 (a)Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. 每一电子签名应是唯一对应单独一个人的并且不能被再使用、或再分配给其他任何人。
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
(a) Forrecords requiredto bemaintainedbut notsubmittedtotheagency,persons may useelectronicrecords inlieuofpaperrecordsorelectronicsignaturesin lieu oftraditionalsignatures,inwhole orinpart,provided that the requirements of this part are met. 需要维护,但不提交给FDA的记录,如果符合本条款的要求,人们可以使...