NK
☆    

India,
2018-08-10 10:43
(1261 d 11:31 ago)

Posting: # 19163
Views: 2,933
 

 Phoenix Connect [Software]

Hi,

While importing the data from Watson LIMS to Phoenix WinNonlin through phoenix connect How the randomization code and actual time of sample collection will be incorporated in Phoenix winNonlin data?

Phoenix will capture audit trail if the project is saved. How about LIMS

Will LIMS capture the audit trails of data transfer?

Thanks in advance.

Regards
NK


Edit: Category changed; see also this post #1[Helmut]
Helmut
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Vienna, Austria,
2018-08-10 11:11
(1261 d 11:03 ago)

@ NK
Posting: # 19164
Views: 2,386
 

 Phoenix’ History-tab ≠ audit trail

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.

Dif-tor heh smusma 🖖
Helmut Schütz
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