My company is entirely new to Software validation/CSV. I have been asked to look into the team set up. First of all, I am not sure if other organizations usually have a dedicated SW validation team.
Right now, I am thinking of setting it up in Quality and reg. department. The team comprising of a few CSV engineers to help with manufacturing Software validation and IT application validation and maybe one Software auditor. Can anyone suggest if this organization set up would be appropriate and can work? There are discussions going on to have a CSV team in the IT department but not sure if that would be the right decision.
Right now, I am thinking of setting it up in Quality and reg. department. The team comprising of a few CSV engineers to help with manufacturing Software validation and IT application validation and maybe one Software auditor. Can anyone suggest if this organization set up would be appropriate and can work? There are discussions going on to have a CSV team in the IT department but not sure if that would be the right decision.
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