您可以使用 Title 21 CFR Part 11 框架来协助您做好审计准备。此框架包括预先构建的控件集合,其中包含描述和测试程序。这些控件根据 CFR 要求分组到控件集中。您还可以根据具体要求,自定义此框架及其控件,以支持内部审计。 以该框架作为起点,您可以创建 Audit Manager 评测并开始收集与您的审计相关的证据。创建评测后...
The regulations outlined in CFR Title 21 Part 11 set the ground rules for the technology systems that manage information used by organizations subject to FDA oversight. Any technology system that governs such GxP processes as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and ...
[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. ...
Source:U.S. Food and Drug Administration – Title 21, Volume 1 CFR11.10 Title 21 CFR Part 11Subpart BLevel of Support & Supporting FeaturesApexSQL Audit Provides Section 11.10 Controls for closed systems § 11.10 (a) – Validation of systems to ensure accuracy, reliability, consistent intended...
为了能够在受监管的条件下使用 X 射线衍射仪,如制药行业中,仪器必须满足诸如 FDA Title 21 CFR Part 11 与ALCOA+ 等特定法规。本文将概述 XRDynamic 500 为满足此类需求所提供的特定功能。 02 软件特色Software features XRDdrive 仪器控制软件,以及 XRDview 数据可视化软件无缝结合了直观的仪器操作以及后续工作流程...
PharmaReady ™ FDA Compliant Document Management System Title 21 CFR Part 11 cross-reference 21 CFR Part 11 RequirementSolution, Pharmaready
XRDynamic 500借助自动多功能粉末 X 射线衍射仪可以获得绝佳的 XRD 数据并拥有更高的测试效率。现已符合FDA Title 21 CFR part 11 与 ALCOA+。直观易用拥有全自动光学元件与自动校准程序,轻松获取高质量 XRD 数据。 制药行业 Pharmaceutical industry 质量控制 ...
Title 21 Code of Federal Regulations 21CFR Part 11 Electronic Records & Electronic Signatures Fast Forward/ Rewind Play It will take 15 minutes to complete this course. Identify types of signatures Determine what records apply to the 21CFR requirement List which systems apply to this requirement ...
CFR - Code of Federal Regulations Title 21 part 11
XRDynamic 500 现已支持 FDA Title 21 CFR Part 11 XRDynamic 500 能以更高效率推动无与伦比的 XRD 数据质量。尽享囊括各种应用的多功能平台所带来的优势,为粉末 XRD、非环境 XRD、PDF 分析、SAXS 等提供更佳解决方案。 使用直观,具有全自动光学和校准程序,它能使每个人从新手变为专***,在更大限度减少...