Do we need to validate Software used in Drug discovery and development process?

#1
Dear Cove Members,

I'm working with a company who is actually a software supplier to some pharmaceutical clients. The software contains curated scientific data from various scientifc journals , patents, articles about Chemical compounds/ Biomarkers to identify potential compounds / biomarkers to be used for research in pre-clinical or clinical studies. From the intended use, the software is not directly used by Pharmaceutical companies to support their GMP, GLP or GCP processes but can be used for making a decision on whether to go ahead with chemical compound and biomarkers to be used in the studies. I have been pulling my hair on whether this software really needs validation or can it be considered non-GxP. Please provide your suggestions.
 
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yodon

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#2
Stop the hair-pulling! :)

Put aside the regulation for just a minute. Does it make good business sense to give you better confidence that the software operates as intended? What's the risk if the software fails? Would you even know it? What assurance is there that the data is good?

Document your decisions / rationale and do what makes sense from a risk and business perspective and then use a comb or brush on your hair.
 
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