Discussion Category:  Software (HPLC)

Adding new HPLC,UPLC or LIMS to Qualified EMPOWER 3


I wanted to know what is level of requalification required when a new 1. HPLC/UPLC or 2. LIMS is added to a existing new qualified EMPOWER 3.

Whats the extent of revalidation required ? What would be validation delieverables required to support this new addition of instrument ?

Do we need to reversion our IOQ  documents ? Do we requalifiy our entire Empower 3 system i.e. Citrix Server, LAC/E s and Empower server ?

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We typically do not have customers whose internal procedures require them to requalify their Empower 3 Software installation after adding an instrument. (However, sometimes some work is done if there is a new instrument driver that is being deployed; sometimes this is just in the form of a PQ on the instrument after it is installed and the Empower SQT products facilitate this.)

The connection LIMS vendors use to communicate is through the software development kit, called Empower Toolkit, which is designed to allow users to integrate, extend and customize Empower without perturbing the core Empower application.  If the vendor is using Toolkit, then Empower need not be requalified.

Here is a brochure for the Empower Toolkit with additional information:

Karen at Waters

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