What's different between Computer System Validation and Software Validation?

COMPUTER SYSTEM VALIDATION (CSV)
1

Dear All,

What’s different between Computer System Validation and Software Validation ?

COTS should be following

(1) General Principles of Software Validation; Final Guidance for Industry and FDA Staff ?

or

(2) GAMP 5

Could you please give me some comments?

Thanks!

2

Computer System Validation (CSV) is a general term. Software validation always is performed as part of the CSV which includes the software and the hardware. More details are needed to better answer your questions since both are guidance documents. The FDA guidance is specific to medical devices related software. GAMP 5 is more general automated systems. Please be more specific.