CFR) (联邦法规包含美国联邦政府行政部门和机构的规章制度。 CFR 的 50 个游戏中的每一个都针对不同的受管制领域。 FDA CFR 第 21 章对美国中生产或消费的食品和药品进行监管,由食品药品监督管理局 (FDA) 、药物执法局和国家药物管制政策办公室管辖。 CFR 标题 21 第 11 部分中概述的法规为管理受 FDA 监督...
Microsoft エンタープライズ クラウド サービスは、FDA CFR Title 21 Part 11 への準拠をどのように示していますか? MICROSOFT は、SOC 1 Type 2、SOC 2 Type 2、ISO/IEC 27001、ISO/IEC 27018 について第三者が作成した正式な監査を使用して、これらのレポートに示されている関連するコン...
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FDA 21 CFR PART 11 Solution Benefits:Meet FDA regulations for electronic records and signatures Achieve compliant document management and records storage Benefit from user/time stamping of records Leverage unalterable document history including baselines Improve management oversight with automated reports...
Please read why experts state, that standalone instruments cannot be 21 CFR Part 11 compliant and concepts offered in the market that look like a feasible workaround are rather dangerous because they may result in a data loss and even worse scenarios. ...
21 CFR Part 11 Compliant Cutting Edge Technology By AlexanderwerkAlexanderwerk, Inc
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 ...
Benefits of 21 CFR Part 11 Compliant Software Data Integrity and Security 21 CFR Part 11 compliancemaintainsthe integrity of electronic recordsandsignaturesto ensure that data isaccurate, reliable,and complete. Incomplete or inaccurate data records can lead toissues of quality or safety concerns for ...
SolstiX XRD Software with Security Suite includes an intuitive user interface that enables pharmaceutical companies to maximize productivity while achieving 21 CFR Part 11 compliance. Using SolstiX XRD Software with Security Suite, lab researchers can achieve compliant workflows using the robust, easy-to...