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Powering the Future of Diagnostics: QSRs and GxP Compliance for Partnering with Pharma and Beyond
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"Powering the Future of Diagnostics: QSRs and GxP Compliance for Partnering with Pharma and Beyond"

Health data is more valuable when shared. This is the view of leading genetic testing companies that are pushing the boundaries to improve human health outcomes and accelerate research with clinico-genomic data. Yet from the perspective of pharmaceutical companies, there is significant exposure to sharing data with third-party partners.

Compliance with Quality System Regulations (QSRs) — also known as GxP compliance — is critical to operating in this heavily regulated environment. Pharma companies and their diagnostic partners are required to meet these QSRs.

This white paper from DNAnexus provides an overview of the FDA’s QSRs and GxP guidelines, describes how to comply with QSRs to form strategic pharma partnerships, and describes how DNAnexus can help companies build and support global compliance collaborations.


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