Software validation team

[Divpara]

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.

 

[yodon]

A lot will depend on the size of your organization and the amount of effort required to keep the systems in the validated state. It would be hard to say whether dedicated engineers would be warranted. Info on how many applications you have, how frequently they change, and what the risks are with the applications would all factor in.

By and large, it shouldn't matter WHO is assigned as long as they are competent to perform the tasks assigned.

 

[Divpara]

Thanks, Yodon. My organization has approx. 5000 employees. I can say it's a midsize company. Validation is a continuous exercise. There is always enough validation work and maybe that's why the organization is looking for a permanent setup, now. Just curious to know if other companies do have dedicated CSV/SW validation teams.

 

[yodon]

I have definitely seen organizations with dedicated CSV/SW validation teams.