1Not for Product Promotional Use

Priya DurvasulaHead of IT, Global Quality

September 17, 2018

Modernizing Quality ManagementRaghunandan Satyanarayan

Associate Director

2Not for Product Promotional Use

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.

2.14

3Not for Product Promotional Use

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

Topics

4Not for Product Promotional Use

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

5Not for Product Promotional Use

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

6Not for Product Promotional Use

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

7Not for Product Promotional Use

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

8Not for Product Promotional Use

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

9Not for Product Promotional Use

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

10Not for Product Promotional Use

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

11Not for Product Promotional Use

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

12Not for Product Promotional Use

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

13Not for Product Promotional Use

Integration Architecture

14Not for Product Promotional Use

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

15Not for Product Promotional Use

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

16Not for Product Promotional Use

Questions?