Валидация компьютеризированных систем
Validation of computerized systems

 

 

Презентации на Русском

Валидация компьютеризированных систем Автор: Денис Островной

 

Статьи на Английском

FDA
	Introduction to the Computer System Validation
	Validation Responsibilities
	Before You Start Validation
	The Process
	Establish Teams(s)
	Determine Activities
	Write the Protocol
	System Development Details
	Perform Qualification Activities
	Develop &  Review  Procedures
	Certify the System
	Review Periodically
	Computer Validation Master Planning
	Computer Validation as a Team Sport: Project Management Issues By Linda Forstedt
	Testing Times in Computer Validation Ian Lucas SeerPharma Pty Ltd.
	Software Structural Testing Methods By George N. Brower Analex Corporation
	A Practical Approach to PLC Validation By Jay H. King formerly Medeva Pharmaceuticals
	Computer Validation. Introduction and basic terminology
	Computer Validation. Regulatory aspects
	Computer Validation. Life cycle of software and systems
	Computer Validation. Risk analysis and system classification
	Validation of computerised systems
	Operation of computerised systems
	Externals service providers