Modernizing Quality Management

Transcription

1 Modernizing Quality Management Priya Durvasula Head of IT, Global Quality Raghunandan Satyanarayan Associate Director September 17,

2 Speaker Information Priya Durvasula, PhD Head of IT, Global Quality 20 years of experience within Pharmaceuticals, Medical Device and Supply Chain Consulting technology deployment. In her current role at BMS, her team is accountable for the strategy, planning and outcomes realization of digital investments for the integrated Global Quality organization. She is a published author in peer reviewed journals for Transportation and Network Optimization. Raghunandan Satyanarayan Associate Director Senior Technology and Management professional with varied experience and expertise spanning 20+ years in IT industry. Currently specializing in Pharma and Health Sciences domain with additional experience across Financial Services, Banking, Insurance, Securities and Capital markets. 2

3 Topics Need for New Quality System Program Approach High-level Timelines Why Veeva? QMS Architecture BMS Platform Strategy Business Benefit and Outcomes Risks 3

4 Enterprise Mindset Horizontal Quality Focus Across the Product Life Cycle We Are Simplifying and Integrating our Quality System Across the Product Lifecycle Current Future Quality Systems 5 1 Key Quality Processes 21 6 SOPs ~ Information Storage Complex hybrid paper and electronic infrastructure Single IT platform GCP GMP- D GQLP GMP- C GDP GxP 4

5 Business Process Integration Good Clinical Practices Good Quality Laboratory Practices Good Manufacturing Practices Development Good Manufacturing Practices Commercial Good Distribution Practices Simplifying and integrating our processes into a new electronic SINGLE platform: Change Management Corrective and Preventative Action Management Deviation and Complaint Management Audits Notification to Management 5

6 Evaluation of Business Process Business Processes 1 3 Proposed Sequence For Deploying Business Processes into QMS 2 Evaluate Each Business Process Compliance Risk Integrations Required Evaluation Complexity Change Readiness WAVE 1 WAVE 2 WAVE 3 Schedule 6

7 Need For a New Quality System Current State Change Management Pre-Approval Process: Future State Complete Change Management Process: Change Management Execution/Closure Process: Fewer process steps Fewer handoffs Fewer approvals Fewer roles Increased efficiency 7

8 High-level Timeline Delivery Phase Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q Scope Wave 1 Wave 1 Go-Live Development Change Control Action Management Wave 2 Wave 2 Go- Live Investigations Commercial Change Control Wave 3 Wave 3 Go-Live Product complaints Audits Notification Management 8

9 Infinity Workshop Design Process Configurations Process Exercises Configuration workshops are designed to review requirements User Requirements Workshop Iteration 1 Feedback Workshop topics are progressive they build in complexity as the project evolves Process Exercises Workshop Iteration 2 Configurations Within each iteration, requirements are refined and the system is configured - the configuration is reviewed in an iterative way until Configuration/Design Lock Feedback Configurations Config Lock Process Exercises allow users to interact with the system and provide feedback on system configuration 9

10 Why Veeva QMS v Enterprise platform v Cloud-based solution v Application integration with regulatory v Seamless process with CMO s, CRO s, and other partners 10

11 Architecture Current Future Future Supplier or Vendor Performance Organization & Governance Development Change Control Data Quality Checks Data Standardization Commercial Change Control Data Modelling Data Extraction & Cleansing CAPA & Standalone Actions Audits & Investigations Product Complaints Enterprise Quality Information Management Future Metrics & Quality Compliance 11

12 Platform Strategy Driving enterprise integration with efficiency and effectiveness Enterprise Platforms Point Solutions Standard Solutions SaaS SaaS On-Premise On-Premise Maintaining the core of our enterprise operations and capabilities Retire Retire Business as a Service 12

13 Integration Architecture 13

14 Benefits and Expected Outcomes Qualitative Benefits Scoped processes harmonized across R&D and GMS By 2Q 2019 Cross Functional Governance team formed By 2Q 2018 Driving Productivity / Agility and Risk Reduction Deployment of collaboration tools to CRO and CMO Vendors Deployment of commercial analytic tools to the Teams 4Q 2019 >=30% Reduction in time for key metric reports Reduction in errors and compliance risk for clinical change control Eliminate paper 14

15 Risks and Early Lessons v Aggressive program timeline v Change readiness in sites; possible use of 2 systems during transition v Aligning BMS process to Veeva s Vault QMS roadmap (EAP) v Process mapping and overall testing and validation strategy 15

16 Questions? 16