Toggle Controls for life sciences to ON. STEP 4 Agree to the disclosure and click EnableKey benefits Easy compliance and validation Tighter authentication to access and sign documents Minimized risks and lowered costs Seamless signing experience Automated workflows What is 21 CFR Part 11? This is a...
This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).Drug Administration (FDA)...
Learn from industry practitioners and experts why implementing a FDA 21 CFR Part 11 Software System is so essential.
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. 在本条款下维护计算机系统(包括硬件和软件)、控制权、和随附的文件应便于被FDA用到,和服从于FDA的监管。
Microsoft enterprise cloud customers may use the audited controls described in these related reports as part of their own CFR Title 21 Part 11 risk analysis and qualification efforts. Customers who build and deploy applications subject to FDA regulation are responsible for ensuring that their ...
Subpart B--Electronic Records 子分章B—电子记录 Sec. 11.10 Controls for closed systems. 11.10 封闭系统的管理 Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when app...
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. 在本条款下维护计算机系统(包括硬件和软件)、控制权、和随附的文件应便于被 FDA 用到,和服从于 FDA 的监管。 (f) ...
(d)Electronicrecordsthatmeettherequirementsofthispart maybeused inlieuofpaperrecords, in accordance with11.2,unless paperrecordsarespecificallyrequired。 依照本条款11。2,除非纸制记录有特殊的要求,符合本条款要求的电子记录可以代替纸制记录使用。 (e)Computer systems(includinghardware and software), controls,and...
Easy to understand answers for how STARe Software provides the technical controls for 21 CFR part 11.
Subpart B--Electronic Records 11.10封闭系统的控制 Sec. 11.10 Controls for closed systems. 使用封闭系统进行创建、修改、维持或传输电子记录的人员应使用经过设计的程序和控制,以确保电子记录的真实性、可靠性以及保密性,并确保签署人不能够以记录不真实为由进行否认。这样的程序和控制应包括如下内容: ...