Bioequivalence and Bioavailability Forum 09:59 CEST

HI NK,

I suggest to register at Certara’s Forum and ask your question there.

» Phoenix will capture audit trail if the project is saved.

I guess you are talking about the History of every object. It is correct that any change will be re­corded if the project is saved. However, it is possible to make changes, run an analysis, and exit with­out saving. Hence, the History does not qualify as an audit trail. If you want to have a CFR Part 11 compliant system you need the Phoenix Knowledgebase Server (PKS).

» How about LIMS
» Will LIMS capture the audit trails of data transfer?

In general, yes. No personal experience with Watson. Please RTFM.

Keep in mind that it is your responsibility to validate the data transfer.
In my old CRO we did it for Agilent’s LAB/UX ⇒ (classical) WinNonlin.