Reporting of QA [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2019-11-11 09:14 (756 d 06:38 ago) – Posting: # 20782
Views: 2,110

Hi,

» If a clinical site have only one PI and there are no other senior person such as Director/Head other than PI. In Such Case QA should report to whom and all the QA SOP should be reviewed &

It is not uncommon that small sites do not have a classical structure with independent QA.
However, such sites are by the nature of the game usually subcontracted by someone who has the overarching QA task, and who does the auditing and final QA review. Therefore, independence of QA, which is a formally enforced requirement, is assured in such cases. The organised system with site investigator files, trial master files, source pave the way for its relatively easy implementation.

The people doing QA at such sites could as well be called something else, like QC employees.

Pass or fail!
ElMaestro

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