•Process/SystemOwner,•SystemCustodian,•QualityAssurance,•RegulatoryAgencies SYSTEMVALIDATIONLIFECYCLE •Strategicthinking ideas Requirement Design Testing •SystemSecurityManagement•SystemInventory•SystemorDataChange•PeriodicalReview•Backup&Restore•DisasterRecovery•SystemRetirement Support&...
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.
However, the three GMP-guidelines imply the same philosophy about computer system validation. They describe more a what-to-do approach for validation, whereas the GAMP Suppliers Guide describes a how-to-do validation. Nevertheless, they do not contain major discrepancies. 展开 ...
Software ValidationEquipment DesignEuropeGuidelinesMedical Informatics ApplicationsSoftware DesignSwitzerlandUnited StatesA 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....
With over 10 years of regulatory and validation experience, we provide high quality services that meet the stringent FDA regulations and exceed your expectations. Our validation methodologies ensure that your computerized system is compliant, reliable, accurate, robust, and effective in meeting your busi...
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 ...
Computer Software Validation and Verification is a standardized process for testing computer software and systems, mandated by FDA 21 CFR 11.10(a) and EudraLex Annex 11, Section 4 regulations for electronic data management systems. Installing and maintaining computer systems in regulated environments req...
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.
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: ...
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 co...