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: ...
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.
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 ...
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网络计算机验证;计算机系统验证;计算机系统的验证
FDA 21 CFR Part 11 / Annex 11 / GAMP™ 5 Assessment Quality assurance review Validation summary report Prerequisites Recently qualified or requalified instrument(s) SOPs as related to the lab system Flexible pricing plans To help you control validation costs, we offer tiered CVS services to fit...
Computer system validation in the phamaceutical industryFerris, Richard
This course provides practical end to end understanding about GxP computer system validation based on real life example. Computer system validation (CSV) is a process used in the pharmaceutical, healthcare, and other regulated industries to ensure that computerized systems are designed, developed, and...
(FDA: General Principles of Process Validation, 1987). 建立文件化的证据,使得具体的进程按照产品既定的规格和质量属性来如一生产提供了保证。 (FDA:工艺验证的一般原理,1987年) Which systems should be validated? Any system that is used to create, modify, maintain, archive, retrieve, or transmit ...