Harsh Shah, Clinplex

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Harsh Shah, Clinplex

I spent 18 years in FDA-regulated operations and quality. I built Clinplex because systems like Veeva, MasterControl and TrackWise are very good at managing controlled documents and workflows, but they don't continuously determine whether the underlying operation is compliant. Clinplex sits above those systems and evaluates documents against regulatory requirements, finds what's missing, connects inconsistencies across records and identifies compliance risk before an audit or submission

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