Insights

Cristina Ferrazzano Yaussy

Having audited more than 300 clinical trials, Cristina is a certified clinical research professional with an impressive array of experience in both industry and academic settings. She obtained a MPH from Case Western Reserve University, has led hundreds of educational presentations both locally and nationally, and has been awarded first honors by several professional research organizations for her work in research compliance and oversight. Cristina currently manages the support infrastructure, delivery of client services, and is the subject matter expert and Agile product owner for Complion, an enterprise-wide platform that enables clinical research sites to centralize and process regulatory documents across their organization.
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Q&A from Document Management Success: A Guide to Part 11 System Validation

Posted by Cristina Ferrazzano Yaussy on Aug 2, 2017 3:03:33 PM

The following is based on the Question and Answer portion of “Document Management Success: A Guide to Part 11 System Validation,” a Complion webcast featuring Michelle Grienauer, JD, MPH, Senior Regulatory Attorney at Kinetiq, and Cristina Ferrazzano Yaussy, MPH, CCRP, VP of Professional Services, Complion, Inc. The webinar explored what clinical research sites should know about validating eRegulatory and document management systems. 

366 individuals from the clinical research industry attended: 31% from an Academic Medical Center, 23% from a Hospital or Health System, 12% from a Dedicated Research Site, 11% from a Cancer Center, 7% from a Physician Practice, and 5% from a Sponsor or CRO. Prior to the webinar, the audience was polled to collect feedback about the current state of document management and validation.

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Topics: eRegulatory, Compliance, Regulatory Compliance, 21 CFR Part 11

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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