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P215: The Benefits and Value of a Single Integrated Electronic Quality Management System across the GxP Product Lifecycle





Poster Presenter

      Cindy Ryan

      • Associate Director, Global QMS Programs
      • Bristol-Myers Squibb
        United States

Objectives

To design and implement an electronic Quality Management system by simplifying, streamlining, and automating multiple disparate processes and systems into a single enterprise strategy spanning the product life cycle, thus reducing overhead cost and process waste.

Method

Comprehensive analysis was performed by core teams comprised of members of key business functions across the GxP product lifecycle. These teams established process flows for each of their “current state” processes. This analysis led to a simplified, streamlined “future state process."

Results

The following are the results and the reduction of waste demonstrated by implementing a single Electronic Quality Management system across the following quality processes; Change Control (Development/Commercial), GxP Deviations, GxP Notification to Management, Product Quality Complaints (Clinical/Commercial), GxP Audits. • Fifteen (15) Unique systems/instances absorbed into a single Quality Management System • Approximately 30K hour reduction in cycle time across the deviation, change control, and Product Quality Complaint workflows. • One Hundred and Three (103) existing system roles streamlined to twenty-nine (29) in the single eQMS. • Reduced Approvals from Twenty-Seven (27) to Nine (9) across workflows. • Product Quality complaints calculated a reduction in cycle times by >3,000 hours per year, lead times reduced from awareness to closure by 2 days/record, system roles were decreased by 50% and 88 duplicative procedures were removed. • Audits and Inspections delivered an enterprise GxP process across product lifecycle which eliminated legacy systems that were disconnected from the network and process. Role disparity was eliminated via an aligned single set of roles across processes. This elimination of redundancy, overlap, and waste resulted in the elimination of 101 documents. • All CAPA for associated GxP workflows located in one system and updated in real time. Resulted in efficient gathering of metrics and real time dashboards. • Training across workflows for four (4) key processes resulted in individual training reduced from 13 hours/user to 5 hours/user. Approximately over 40K training hours saved for the user population. 62% Reduction in ongoing QMS training. • Overall 212 procedural documents eliminated. 66% gain in efficiency due to streamlined processes and procedures.

Conclusion

The implementation of a single Quality Management System has been a significant transformational change for BMS delivering important quality and business benefits. As a key enabler of our Global Quality Vision, our new business processes and new state-of-the-art cloud based eQMS have transformed how we do business across our key business functions including R&D and Medical Affairs. Harmonizing these business and electronic processes across GxP domains and across the product lifecycle is unique to the industry in a company the size of BMS and provides BMS with a competitive advantage over other top Biopharma companies. BMS has been set apart from our competitors by accomplishing the following: • Standardizing processes and workflows across GxP domains to maximize simplicity, eliminate redundant local procedures and establish a common way of working across business units. • Making data transparent and in a format that can drive data extraction, analysis, risk identification, mitigation and decision-making. • Reducing cycle time and improving speed-to-market by eliminating process waste, unnecessary steps and roles and non-value added activities from our quality processes. • Implementing an innovative risk-based computer system validation testing at the platform and workflow levels maximizing testing efficiency and compliance with data integrity and computer systems validation requirement • Integrating to other BMS computer systems and platforms to eliminate manual work, transcription and improve efficiency by capitalizing on opportunities to enable automation. • Developing a people change management and communication strategy for deployment of enterprise systems to engage prospective and existing users and offering them a forum to share lessons learn and continuously improve. This has allowed us to manage significant changes across BUs in a seamless, non-disruptive manner.