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 ...
计算机化系统验证(Computer System Validation) 以EU、US、WHO、PIC/S、TGA等法规要求为依据,遵循行业内最新国际上通用的良好实践—ISPE GAMP5《良好自动化生产实践指南》,提供高质量、高标准、高效率的计算机化系统验证及合规咨询服务。 我们提供计算机化系统验证服务包括: ...
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: ...
Computer system Validation 计算机系统验证 Process Control System 工艺控制系统 ... cubicpharma.com|基于2个网页 3. 计算机系统的验证 ...onic Records; Electronic Signatures)。只是在合规认证或认可的时候,必须提供完整的计算机系统的验证(Computer Syste…blog.sina.com.cn|基于2个网页...
Kneat Gx | Paperless Computer System Validation 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 comp...
plan to enable you to meet your regulatory requirements, our Computer System Validation Service can help you. 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....
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
This system comprises a removable program source (9,12,14), memory means (3,9) for storing program instructions; a CPU (1) for executing stored program instructions, means (2) delivery characteristics, and access enable means for accessing at least one characteristic and including means for com...
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. ...
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...