DECEMBER - 20209TECH OUTLOOK· How will the data be used and accessed, and what impact would that have on performance (e.g., real-time access would be beneficial for daily decision-making but could impede overall system performance)?· What are the validation requirements for data consolidated into a single BI tool?· Will any broader business practices need to change?The QUADS team engaged the business owners and technical teams for each source system to address these questions and ensure that end user needs for an intuitive interface, fast performance, and trusted data were met. Validation was a critical area where historic paradigms needed to be challenged and robust validation principles applied. Collaboration with the business owners for the source systems allowed for proper understanding and insights on the historic data and the associated business rules employed by the user community for these systems, and also provided the appropriate user scenarios to ensure the data was correctly mapped and calculated.According to Daly, "The real key was asking the right questions and aligning all of the impacted parties on the BI solution, as well as anticipating additional areas that could be pulled into the solution in the future. I believe that's the key to determining the success of a solution and what its ultimate value will be for your operations."Realizing the BenefitsThe specific goals of QUADS were to replace manual effort, improve data integrity and enable innovation. To date, QUADS has yielded new efficiencies in accessing key compliance and operational KPI dashboards, and enabled timely decision making and resource allocation. The time needed to generate critical, validated reports for management review and regulatory reporting was reduced by several orders of magnitude. QUADS' modular design will allow for future expansion and its standardized metrics and consistent data interpretation are already helping to support an increasingly data-centric, quality-minded culture within Celgene.QUADS helped to create a foundation for success and competitive advantage in the digital age by creating a scalable, integrated data layer with key elements from Enterprise Resource Planning (ERP), Quality Management System (QMS), Laboratory Information Management (LIMS), Learning Management (LM), Controlled Document Management, and Service/Project Management systems, and then overlaying a Business Intelligence and Reporting layer with a single, intuitive user interface and fully validated outputs.After implementation, Maria Brown, Executive Director of Global GMP/GDP Compliance and QUADS Project Sponsor, remarked that "QUADS is an amazing enabler that will transform the way we do business." Paul Daly also reflected that "it's a transformational application for our organization, and it's tracking to be the highest ROI value we've ever achieved on a quality CAPEX project."SummaryAs this case illustrates, the advent of systems technologies into the pharma space has opened the doors to new and efficient ways of not only accessing data, but also realizing its power through informative and predictive analytics. Gone are the days of "pull-collate-present." Data-driven analytics, compliance, and quality are the drivers of best-in-class operations where the true promise is quality to the patient. QUADS is a unique and innovative tool that is helping Celgene keep that promise. QUADS' modular design will allow for future expansion and its standardized metrics and consistent data interpretation are already helping to support an increasingly data-centric, quality-minded culture within Celgene
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