The highly-regulated nature of the pharmaceutical industry – coupled with historically siloed organizational models and mergers and acquisitions that introduce disparate operational and IT systems to the enterprise – often presents barriers to change and innovation. Throw in the need to store, organize, analyze, interpret, and report on ever-growing amounts of data from those myriad systems. Then add an evolving focus on quality metrics by regulatory authorities, and it’s clear that business as usual in the pharmaceutical industry will not keep pace in the digital age. A new approach, grounded on innovative IT capabilities, is necessary to succeed and adequately serve patients whose lives depend on existing therapies or who are looking for that next medical breakthrough to treat their life-threatening diseases.
"QUADS has yielded new efficiencies in accessing key compliance and operational KPI dashboards, and enabled timely decision making and resource allocation"
Celgene Corporation was determined to find a single business intelligence (BI) solution that would integrate data from multiple operations and quality management systems into a single destination to empower the business and allow end users to more easily navigate and utilize their data. Or as Art Malian, Senior Director, Business Intelligence & Master Data Management, summarized it, “We needed to create a unique, purpose-built data repository to enable integrated reporting, analytics, and data visualizations that support our quality and operations processes.”
According to Paul Daly, Corporate Vice President for Global Quality Operations, “Our previous systems were manual and time consuming, which took away from the time we could spend on analysis and decision-making. In addition, with an eye always on compliance, we recognized the general inherent risks present when data is stored in different systems and of their often heavily manual reporting capabilities.”
Celgene implemented the Quality Analytics and Decision Support System (QUADS) as a comprehensive data integration and analytics solution. To arrive at this solution, they first had to answer some key questions:
• How do we pull data together from systems that were not designed to talk to one another?
• Will the source system or BI tool require changes to make those connections?
• How do these changes fit into our overall master data management strategy?
• 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.”
The 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 Systems (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.”
As 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 realizingits 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.