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Валидация компьютерной системы
Computer Systems and Software Validation

 

 

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

 

 

 

 

 

 
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