bms-modernizing quality management - veeva systems€¦ · modernizing quality management...
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1Not for Product Promotional Use
Priya DurvasulaHead of IT, Global Quality
September 17, 2018
Modernizing Quality ManagementRaghunandan Satyanarayan
Associate Director
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Priya Durvasula, PhDHead of IT, Global Quality20 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.
Speaker Information
Raghunandan SatyanarayanAssociate DirectorSenior 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.
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• Need for New Quality System• Program Approach• High-level Timelines• Why Veeva?• QMS Architecture• BMS Platform Strategy• Business Benefit and Outcomes• Risks
Topics
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We Are Simplifying and Integrating our Quality System Across the Product Lifecycle
0 Enterprise Mindset – Horizontal Quality Focus Across the Product Life Cycle
1 2
3
Current FutureQuality Systems 5 1Key Quality Processes 21 6SOPs ~300 50Information Storage Complex hybrid paper and
electronic infrastructureSingle IT platform
GCPGQLP
GMP-D GMP-
C GDP
GxP
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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
ManagementAudits Notification to
Management
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Evaluation of Business ProcessBusiness Processes
1
Evaluation
Compliance Risk
Integrations Required Complexity
Change Readiness
Evaluate Each Business Process
2
Proposed Sequence For Deploying Business Processes into QMS
Schedule
WAVE 1
WAVE 2
WAVE 3
3
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Current State Future StateChange Management Pre-Approval Process:
Change Management Execution/Closure Process:
Complete Change Management Process:
Fewer process stepsFewer handoffsFewer approvals
Fewer roles
Increased efficiency
Need For a New Quality System
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High-level Timeline
Delivery Phase2018 2019 2020
Scope1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q
Wave 2 Go-Live
Wave 1 Go-Live
Wave 3 Go-Live
Wave 1
Wave 2
Wave 3
• Development Change Control
• Action Management
• Product complaints• Audits• Notification Management
• Investigations• Commercial Change
Control
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Infinity Workshop Design Process
Iteration 1
Iteration 2
Configurations Process Exercises
Feedback
Process Exercises
Workshop
Configurations
Feedback
Configurations
Config Lock
Workshop
User Requirements
Configuration workshops are designed to review requirements
Workshop topics are progressive –they build in complexity as the project evolves
Within each iteration, requirements are refined and the system is configured - the configuration is reviewed in an iterative way until Configuration/Design Lock
Process Exercises allow users to interact with the system and provide feedback on system configuration
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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
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Architecture
Current
FutureSupplier or
Vendor Performance
Metrics & Quality
Compliance
Org
aniz
atio
n &
Gov
erna
nce
Development Change Control
Commercial Change Control
CAPA & Standalone
ActionsAudits &
InvestigationsProduct
Complaints
Enterprise Quality Information ManagementData Quality
Checks Data Modelling
Data Standardization
Data Extraction & Cleansing
Future Future
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Platform Strategy
SaaS
On-Premise
Retire
Standard SolutionsPoint Solutions
SaaS
On-Premise
Retire
Enterprise Platforms
Business as a ServiceMaintaining the core
of our enterprise operations and
capabilities
Driving enterprise integration with efficiency and effectiveness
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Integration Architecture
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Benefits and Expected Outcomes
Scoped processes harmonized across R&D and GMS
By 2Q 2019
Cross Functional Governance team formed By 2Q 2018
Deployment of commercial analytic tools to the Teams
4Q 2019
Deployment of collaboration tools to CRO and CMO
Vendors
>=30% Reduction in time for key metric reports
Driving Productivity / Agility and Risk Reduction
Qualitative Benefits
Reduction in errors and compliance risk for clinical
change control
Eliminate paper
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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
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Questions?