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Back to the forum  Query: 2017-06-25 05:37 CEST (UTC+2h)
 
Quality-RJ
Junior

Jordan,
2017-06-06 11:51

Posting: # 17449
Views: 317
 

 LIMS [Regulatives / Guidelines]

Dear All
can you advise what is the most commonly used and accepted LIMS system (vendor) to be used in CROs for equivalence
knowing that we have Agilent LCMSMS and API sciex LCMSMS so it is better if compatible with both
thanks in advance for help
Helmut
Hero
Homepage
Vienna, Austria,
2017-06-06 13:20

@ Quality-RJ
Posting: # 17451
Views: 246
 

 LIMS

Hi Quality-RJ,

» can you advise what is the most commonly used and accepted LIMS system (vendor) to be used in CROs for equivalence

Watson LIMS (ThermoFisher Scientific) is quite popular.

» knowing that we have Agilent LCMSMS and API sciex LCMSMS so it is better if compatible with both

Be aware that no LIMS will work “out of the box”. You have to define the system specification before you invite offers. An import aspect: Is it possible to adapt the LIMS to your current workflow? It is your responsibility to validate the system (three levels: installation qualification ⇒ operational qualification ⇒ performance qualification. See here, slides 8–19).
Since no vendor of commercial software will allow access to the source code, your only option is a “black box” validation. A “white-box” validation is possible with open-source software (e.g., Open-LIMS) but that requires a lot of coding expertise.
When we validated our LIMS (HP LAB/UX) we evaluated three BE-projects in parallel (stand-alone CDSs vs. the LIMS). BTW, we had chromatographs of three manufacturers and none of them was from HP (now Agilent). We passed our first GLP-certification in 1997…

[image]All the best,
Helmut Schütz 
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