Erin Wright serves as product validation manager, MasterControl. She has supported regulatory audits for customers throughout her career and is an expert in quality and validation as they apply to regulated industries. She has hosted and participated in hundreds of audits for regulated software, including high-risk software for patient randomization and drug-dispensation to low-risk automated test software.
Wright joined MasterControl in 2013 as a professional services consultant and worked closely with FDA’s Center for Drug Evaluation and Research (CDER) as well as hundreds of regulated companies, including Ancestry.com, Abbott Point of Care, Institute for Transfusion Medicine (ITxM), and the University of Utah, in conducting custom validation implementations. Her extensive experience in quality, validation, and regulatory compliance includes working for an automated-testing software company and several clinical-trial software providers.
For more details, please visit MasterControl at Booth #1583 at MD&M West February 11-13, 2020.