I appreciate that it is the responsibility of the investigator site to produce and maintain a comprehensive and effective QMS system, including maintaining it's own high quality audits.... Which is fine..

But, I don't appear to have ever seen universal tools (outside of legislation and gcp) that ensure that SOP's and audits are effectively been maintained to the same standard. This includes internal audits of clinical trials ensuring that they are inspection ready.

Perhaps that's just asking for too much common sense, or perhaps it's not feasible?

I am particularly interested in good high quality audit tools though.

Does anyone have any recomendations?

Many thanks