Phoenix’ History-tab ≠ audit trail [Software]

posted by Helmut Homepage – Vienna, Austria, 2018-08-10 13:11 (2500 d 15:10 ago) – Posting: # 19164
Views: 3,882

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 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,672 registered users;
18 visitors (0 registered, 18 guests [including 17 identified bots]).
Forum time: 04:22 CEST (Europe/Vienna)

To call the statistician after the experiment is done
may be no more than asking him to perform a postmortem examination:
he may be able to say what the experiment died of.    R.A. Fisher

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5