You can go through the link - www.fda.gov/files/medical%20devices/published/General-Principles-of-Software-Validation---Final-Guidance-for-Industry-and-FDA-Staff.pdf
Hi sir, You have mentioned that we need to perform CSV for any application, then a separate document required for CSA. Separate document means it's like a checklist kind of document whether all the CSA requirements are fulfilled or not we need to check?
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Thank you so much sir.. For your guidance
Welcome
Good evening sir please share FDA guideline link of CSV Other than Gamp
You can go through the link - www.fda.gov/files/medical%20devices/published/General-Principles-of-Software-Validation---Final-Guidance-for-Industry-and-FDA-Staff.pdf
Please share link to refere guidlines
Which guideline link you need. So that, i can share with you
Good evening sir
Good Evening dear. Sorry for the late reply..
Hi sir, You have mentioned that we need to perform CSV for any application, then a separate document required for CSA.
Separate document means it's like a checklist kind of document whether all the CSA requirements are fulfilled or not we need to check?
It is not just checklist
Good evening sir
Good Evening dear. Sorry for the late reply..