Dear All,

We are a clinical research Organisation providing phase II clinical trials services to clients, basically we conduct clinical trials according to the protocol and forward the results to the clients, my doubt is should we be exempted from Clause 7.5.2 on validation of processess for production and service provision.

Thanks in advance

Hi Jay,

I have moved your question to this appropriate section to get more responses :)

any answers ?

I assumed that you are providing a professional service to a specific segment in the medical market. You've to ask yourself whether is there any danger that incorrect professional advices are given - the results of which may become apparent only after sometime.

Generally, this clause is applicable for service organizations providing professional advice.