JVT

Device Validation Forum: Lifecycle Considerations for Device Software

KEY POINTS The following key points are discussed: 
Methodology and documentation recommended by FDA to effectively address lifecycle considerations in software development. 
Basic principles can be applied to software used in processes, production equipment, facilities, test equipment, and other applications. 
“Lifecycle” includes development, initial release, updates, and other activities through final retirement and de-commissioning. 
Software is significantly different from hardware in current good manufacturing practice requirements. Software engineering needs an even greater...

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