Audits

[qamanager]

Hi

What are the requirements for auditing laboratories that perform the storage and analysis or evaluation of clinical trial samples?
Can this be done via an audit checklist followed up by an onsite audit if neccessary?
Thanks

[ashirve]

Refer to guidance document published by MHRA. It is an excellent guide detailing enough info to stay compliant with the regulations.
Audit checklists are brilliant, but don't make the habit of sticking to your checklist only. The problem I observed is that if you stick to the checklist there is a risk that you focus on minute things and don't look at the bigger picture.