FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, an...
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: Knowledge and experience—no one has a ...
Benefits of our on-site Computer System Validation Service include: Knowledge and experience—no one has a longer history of designing, building, testing, and validating our systems in complex laboratory environments than us who made them. Cost control—our ...
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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, Regulatory Compliance and Lab Equipment Qualification.. The consultants at Ridge Pointe Consulting are leaders in the pharmaceutical industry regarding Computer Systems Validation. With over 10 years of regulatory and validation experience, we provide high quality services that mee...
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.
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...
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...
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. ...