ProcellaRX, LLC
Grace Shaw is a seasoned professional in Global Compliance Strategy and Computer System Validation with extensive experience in the Life Sciences and Health Care sectors. Currently, as the VP of Global Compliance Strategy and Solutions at ProcellaRX, LLC, Grace leads global compliance initiatives. Previous roles include managing computer systems validation activities at Cook MyoSite, serving as CSV Lead at Viatris, and holding various positions at MYLAN N.V. that established a strong foundation in regulatory compliance and validation practices. Grace's educational background includes a Bachelor of Arts in English from the University of Maryland and an Associate of Arts in General Studies from Montgomery College.
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ProcellaRX, LLC
ProcellaRX, LLC provides digital validation / digital transformation solutions for software quality testing within life science industry. Our specialized computerized system validation (CSV) / computer software assurance (CSA) and project/quality management services for the pharmaceutical, biotechnology and medical device industries help meet regulatory compliance requirements and supply quality assurance peace of mind. We focus on providing our clients with risk-based agile approaches to best balance regulatory compliance with business need. Our team continues to earn its reputation for customer satisfaction through years of forward thinking thought leadership in computer system validation. Our expertise has been applied across a large variety of systems using a practical, time-tested, efficient and defensible approach to CSV to determine whether designated systems performs their intended functions accurately and reliably. As companies accelerate their digital transformation initiatives, our consulting practice and advisory services focus on digital validation solutions, increased utilization of automation, testing tools implementation and enablement to accelerate the success of our customers with their journey.