Using Big Data to Take Quality Beyond Compliance
So often quality, and the associated quality management system (QMS), focuses on complying by putting out fires. But there’s far more to quality than compliance, and quality doesn’t have to be reactive. This session will discuss the future of quality and how emerging technologies are paving the way for improving quality and making it relevant to those outside the quality department.
Life sciences companies collect so much data through corrective and preventive action (CAPA), deviations, nonconformances, customer complaints, etc. However, those data rarely get used to their full potential. Data analytics can give you business insights to determine which products are most problematic, how employees perform, and which stages of the product development process are the least efficient.
Analytics can predict how your processes will be affected by certain changes. Better than trial-and- error, this method lets you pinpoint specific improvements that will immediately generate results as opposed to trying a new approach for a few months and hoping for positive change.
New technologies require alignment with senior management, which is difficult to get if they don’t see how quality benefits the company’s overall goals. If your company has avoided trouble with a regulatory body, management might not see value in investing in quality. But consider this: being compliant keeps you in business; improving quality keeps you ahead of your competitors.
Sue Marchant will explain how to take your company from reactive to proactive quality management. You’ll see how a QMS solution can give you business intelligence insights to both understand your processes and how to improve them.
• How to use quality data to assess risk.
• Ways to use predictive analytics to gauge how certain factors affect cycle times.
• Making quality important to management by connecting it to the organization’s KPIs.
Sue Marchant Sue Marchant is the director of product, machine learning (ML) and artificial intelligence (AI), at MasterControl, where she is responsible for infusing the advanced data mining and analytics capabilities afforded by these technologies into MasterControl’s cloud-based product life cycle excellence software for the life sciences. She spearheads initiatives around actionable, predictive insights and optimized efficiency, productivity and compliance.
In the decade prior to joining MasterControl, Marchant worked in several senior-level capacities to lead natural language understanding (NLU), ML and cloud analytics projects for NICE Systems Ltd., a cutting-edge text and speech analytics software company that enables organizations to operationalize big data. Her most recent role with the company was director of product. Among her other professional accomplishments, Marchant founded and served as the chief product officer of a SaaS company that developed applications to help hospitals recover the cost of donated prescription medications. She also worked for nearly a decade as an independent consultant in product management, quality assurance (QA) and technical writing in the software space.