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Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

[fa icon="calendar'] Sep 1, 2016 3:46:59 PM / by Pat Flanders posted in Quality & Compliance, Audit, Certification

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Theranos, the once-hot clinical testing start-up, has taken a beating in the press recently. With almost $700 million in venture funding and buttressed by promises of dramatically new and better ways of testing blood samples, the company was once poised to be a model for life sciences companies of the future. Agile and smart, Theranos rapidly moved into a huge market on the back of its proposed innovative solutions.

"...given the amount of scrutiny they're under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects."

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Case Study: How Qualio helped eHealth Technologies achieve SOC 2 Type II Certification

[fa icon="calendar'] Aug 16, 2016 1:34:12 PM / by Anoop Aulakh posted in Case Studies, Digital Health, Audit, SOC2 Type II

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eHealth Technologies’ success revolves around its ability to securely and responsibly handle sensitive patient information. Each time a contract is signed with a new customer, a thorough due diligence process takes place, which includes a security assessment verifying up to 300 items.

 In 2015, the company sought to streamline this time consuming process as its business expanded. To do so, eHealth Technologies required an external security audit to achieve Service Organization Control No. 2 (SOC 2) Type ll Certification. This certification could be presented to customers in lieu of the lengthy security questionnaire, and the credentials would help establish trust in addition to reducing the time and cost of due diligence.

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