雖然沒有符合 CFR Title 21 第 11 部分的認證,但下列 Microsoft 企業雲端服務已進行獨立的第三方稽核,這可能有助於客戶進行合規性工作。 這些服務包括: Azure:雲端服務、記憶體、流量管理員、虛擬機器 和 虛擬網路 Azure DevOps Intune Dynamics 365 和 Dynamics 365 美國政府 ...
CFR Title 21 Part 11 では、電子レコードと署名が信頼でき、信頼性が高く、同等の代替品として紙のレコードや手書き署名に置き換わるよう要件を設定します。 また、FDA 規制業界のコンピューター システムのセキュリティを向上させるためのガイドラインを提供します。. 対象企業は、プロセス...
Focuses on the United States Food and Drug Administration's (FDA) Rule 21 CFR Part 11 which provides criteria for acceptance by the FDA of electronic records and electronic signatures. Basic two parts of part 11; When records must be kept electronically; Importance of security of laboratory ...
主页 产品 溶出度 21 CFR Part 11 Compliant 21 CFR Part 11 Compliant 中国总部 | 其他分公司 北京市朝阳区望京北路 3 号 100102 全球电子邮件 +86 800-820-3278 +86 400-820-3278 全球联系电话 关于安捷伦 新闻中心 公司信息 投资商关系 工作 社会关系 与安捷伦合作 大学关系 环境、社会和公司治理 ...
■ Compliance with FDA 21 CFR Part 11 Using IRsolution The following components are required for compliance with FDA 21 CFR Part 11 when using a Shimadzu FTIR system: IRsolution Ver. 1.10 or later IRsolution Agent Ver. 2.11 or later (equipped with Agent Manager, User Authentication Tool, and ...
Substituting paper records and handwritten signatures with electronic records and electronic signatures is a must for medical device manufacturers to achieve fast compliance with FDA 21 CFR Part 11. With Polarion's template you can exceed the requirement out-of-the-box....
LABELING SOFTWARE FOR FDA 21 CFR PART 11 Regulatory compliance through label management LABEL ARCHIVE for label Storage & security Multi-stage approval of label designs by reviewers Establish permissions to control access Keep record of changes, comments, revisions, and print history of every label ...
21 CFR Part 11 compliance is supported by STARe thermal analysis software. Part 11 gives detailed guidelines on how to manage electronic records and electronic signatures in order to maintain accuracy and security.
内容提示: December 21, 2011 21 CFR Part 11 Compliance Approval Processes, Security, Technology and 21 CFR Part 11 For anyone automating regulatory compliance document flows, there's clearly a challenge in defining what's required to conform to 21 CFR Part 11. When applying 21CFR Part 11 ...
21 CFR Part 11 Compliant eSignature Platform Utilization of current security technologies and procedures to ensure system/network security and data protection, and controlling of access to sensitive data and applications which modify the data.