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NK ☆ India, 2018-08-10 12:43 (2078 d 20:24 ago) Posting: # 19163 Views: 3,684 |
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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] |
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Helmut ★★★   Vienna, Austria, 2018-08-10 13:11 (2078 d 19:55 ago) @ NK Posting: # 19164 Views: 3,007 |
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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]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz