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...
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...
21 CFR Part 11 -- Electronic Records; Electronic Signatureswww.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11 Subpart B—Electronic Records电子记录 11.10 Controls for closed systems.封闭系统的控制 Persons who use closed systems to create, modify, maintain, or transmit electronic reco...
(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)This part...
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, integ 26、rity, and, when ...
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, o transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when ...
Learn from industry practitioners and experts why implementing a FDA 21 CFR Part 11 Software System is so essential.
適用於機器視覺系統的特定部分為第 11 部 B 分部 (Part 11 Subpart B),標題為「管控封閉式系統」(controls for closed systems)。其提供六個主要方面的指引: #條例描述 11.10(a) 驗證 驗證系統以確保準確度、可靠度、一致性 11.10(b)(c) 記錄複本與保護 產生適合用於檢測的準確記錄複本 11.10(d) 系統存取...
(d)Electronic records that meet the requirements of this part may be used in lieu of paper records, in accorda nee with 11.2, uni ess paper records are specifically required. 依照本条款 (e)Computer systems (includinghardware and software), controls, and attendant docume ntati on maintained un...
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: ...