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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