这一方面的内容很多,比如IPSE中关于计算机系统验证都有几个报告,内容很多,目前国内就只关注GAMP5,其实ISPE还有专门关于实验室计算机验证的报告等待好多的,而中英文版本还是比较罕见的资料计算机系统验证主计划(中英文对照).pdf
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Kneat Solutions’ next generation paperless validation software “Kneat Gx” digitizes the entire computer system validation life-cycle, delivering compelling productivity, cycle-time and compliance improvements. Kneat Gx allows you to manage all your computer system’s life cycle starting with requireme...
Our professionals—working closely with your staff—can help you get into production faster, at the same time also allowing you to control validation costs and manage your compliance risk. Benefits of our on-site Computer System Validation Service include: ...
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Computer System Validation 文档格式: .pdf 文档大小: 1.46M 文档页数: 8页 顶/踩数: 0/0 收藏人数: 0 评论次数: 0 文档热度: 文档分类: 待分类 文档标签: ComputerSystemValidation Computer System Validation,Computer System Validation,Computer,System,Validation ...
Computer system validation or CSV is also called software validation. Regulated companies must prove with evidence that their software systems are performing as they are intended to perform correctly every time. According to the FDA, the general principle of software validation is “Confirmation by ...
David Nettleton is an FDA Compliance, 21 CFR Part 11, Computer System Validation, Software Implementation, Computer Software Assurance, and HIPAA Specialist for healthcare, pharmaceutical, and medical device applications.
David Nettleton is an FDA Compliance, 21 CFR Part 11, Computer System Validation, Software Implementation, Computer Software Assurance, and HIPAA Specialist for healthcare, pharmaceutical, and medical device applications.
A brief overview of the relevant documents for companies in the pharmaceutical industry, which are to be taken into consideration to fulfil computer system validation requirements, is presented. We concentrate on official requirements and valid standards in the USA, European Community and Switzerland. ...