To watch the full webinar, register here: https://go.veeva.com/modernquality_webinar2020 Watch this short video to learn more about our upcoming webinar “Modernizing Quality Management”: http://bit.ly/2U8cIAp Addressing drug shortages and the development of new complex therapies — two top challenges facing manufacturing organizations — require the transformation of quality management using modern systems. In this webinar, Veeva’s Mike Jovanis, VP of Vault Quality, and Ashley Wentworth, director of quality strategy, will discuss how modern quality systems automate business processes, connect global partners and suppliers, and enable manufacturing agility. Register for this webinar to learn how: • Industry trends are driving quality management transformation • Digitizing manufacturing operations can drive quality improvements • Companies are benefitting from modern quality systems based on real-world examples Learning Level: Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. Who Should Attend: • Employees of pharma manufacturing, generics, and CMO organizations • Quality professionals involved with quality systems, quality operations, or GxP Compliance Speakers: Michael Jovanis, VP Vault Quality, Veeva Systems Ashley Wentworth, Director Vault Quality, Veeva Systems

1. Modernizing Quality
Management
Improve Quality and Compliance

2. Michael Jovanis
VP, Vault Quality
Director, Vault Quality
Ashley Wentworth

3. 3Copyright © Veeva Systems 2019
Agenda
Drivers for modernizing quality systems
1
Transforming content management
2
Unified and connected
3
Consistency of industry best practices
4
Intelligent data-driven decisions
5
Q&A
6

4. 4Copyright © Veeva Systems 2019
The Industry Has Changed
Globalization &
Externalization
• Quality processes extend to
partners, yet systems are only
internally accessible
• Continued globalization of supply
chain
• Lack of global visibility across
internal and external quality
Increasing Complexity
• New products – biosimilars,
combination products, and non-
biological complex drugs are
more involved to manufacture
• Personalized medicines creates
new challenges for quality
organizations
More Regulations, Complex
Enforcement
• Meeting new and changing
regulations is onerous
• Differing quality standards — mfg
site is different than country of
approval
• Compliance is complex and
impacts agility

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Externalization
• Connecting internal and external parties
• Natural resolution of a risky disconnect point
Aging Solutions
• Existing solutions implemented reactively
• Confining, non-agile process
• Do not reflect today’s user experience expectations
Simplifying
Complexity
• Enable seamless processes across solution areas
• Incorporation industry best practices
Drivers for Modernizing Quality Systems

6. Polling Question #1

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Evolution of Adoption of Quality Systems
Emergence of
21 CFR Part 11
Replacing home
grown apps &
manual processes
Remediation of
specific compliance
challenges
Fragmented, quality
systems not viewed
as strategic
1990 Present
Day

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Investment in Quality Solutions
• Many smaller incremental projects over the past 20 years
• Cyclical investment is based on compliance issues and individualized
investments
1990 Present Day
Investment
Transformative
Investment
20 years of smaller projects

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Industry Shift Requires Different Perspective / Thinking
Incremental Investments
• Incremental, smaller
investments over time
• Fragmented landscape
Large Transformative Projects
• Singular, enterprise / global
quality projects
• Little experience building a
transformative business case
True Shift to the Cloud
• Significantly different TCO
footprint and a large
investment
Opportunity for Value
• Great opportunity for
creating value, quality is not
just achieving compliance
?

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Opportunities for Quality
Consistency of
Industry Best
Practices
Unified and
Connected
Transforming
Content
Management
Intelligent Data-
driven Decisions
Transforming
Quality

11. Transforming Content
Management

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Transforming Content Management
Video-based
Content Delivery
Tablet Delivery on
Shop Floor
Collaborative
Authoring
Intersection of
Content and Data
>
• Lack of innovation in the content management space has created many
opportunities
• Digitalization is an enabler

13. Unified and Connected

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Quality Unification
Applications QMS Elements Interconnections Collaboration
Unification of multiple
disparate quality
applications onto a single
platform
All QMS elements unified
with standardized
processes and data
model
Interconnections
between applications are
standardized and
maintained
Real-time collaboration
on processes,
documents, and data
across all stakeholders

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Unifying Systems Across Functional Areas
Quality
Event
Implementation Actions
Regulatory Actions
Document Change Control
CAPA
Change
Control
Better Intelligence
Seamless Process
Accurate Product
Releases
Automated Re-Training
Qualify by
Role
QMS

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Seamless Change Control with Content
• Eliminate multiple systems and complex integrations
• End-to-end workflow visibility and automation
• Documents can be grouped by common authors and reviewers, grouped into role-based curricula, and
associated with one or more change actions
• “Just-in-time training” to optimize compliance readiness
Document(s)
Change Action
Change Request Change Actions
Completion
Impact
Assessment
Change Plan
Creation
Pre-Approval
Post Approval
Coordinated
Change/Doc Release
Closure
Auto Re-training
Triggered
Qualification
Verification

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Business Process Unification – Quality and RegulatoryQUALITYREGULATORY
Change
request
triage
Open
change
request
Define change
management
plan
Impact
assessment
Change
activities
Execute
change
order
Approve
& release
change
order
Shipping /
distribution
Implement
change
order
Regulatory impact
assessment
Regulatory
filing
updates
Regulatory / country approvals
Real-time visibility
into approvals
Approve
change
request
plan
Which
markets are
affected?
Yes we can
ship the
product to
Canada?

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Quality Risk Management
Risk Lifecycle
Workflow to
Enable
Transparency
and
Collaboration
Operational
Risk Register
Risk 1
(Score 100)
Risk 2
(Score 30)
Mitigation
Actions
Mitigation
Actions
Supplier
Risk Register
Risk 1
(Score 80)
Mitigation
Actions
Closed
RISK LIFECYCLE WORKFLOW
Residual RiskRisk
TreatmentEvaluateAnalyzeIdentify

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ERP Integration
ERP
QMS
Place batch
restrictions
Update and/or batch
restrictions
Quality Event
Initiation
Triage & Impact
Assessment
Investigation &
Disposition
CAPA Planning
& Execution
Traceability to
Change Control
Batch/Lot/Material/
Equipment Lookup
and Association

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Departments
Suppliers
Contract
Manufacturers
CROs,
Test Labs
Secure
Any Device
Easy
Integrating Internal and External Sites
Quality
System
Use Cases
• Batch disposition and
release
• Technology transfer
• Stability test review and
acceptance
• External audits
• Protocol and method
collaboration

21. Consistency of Industry Best
Practices

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Consistency and Standardization
Industry best practice based delivered
applications
Standardizing on metrics and
reporting
Seamless communication across
applications

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Cloud Technology
Multitenant Cloud
Always current
Never stuck
Best performance
(software optimized
Cloud Delivery
Easy access
Lower infrastructure
costs
Better performance
(hardware optimized)
Industry Cloud
Designed for greater
control
Industry best practices
Validation

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Benefits of Industry Cloud
• Built-in best practices for life sciences
• New industry features for evolving business
requirements
• Built to support regulatory compliance
• Secure, easy access on any device, from
anywhere
• Intuitive, requires less training
• Easily bring partners into the environment
• 100% multi-tenant SaaS, zero footprint
• Built-in industry best practices, storage, backup,
and archive
• Secure, different levels of access
• Configure to adapt
• On-demand scalability
• Single version, always current
• Pre-validated: IQ/OQ validated, PQ ready
For Business For IT

25. Intelligent Data-driven Decisions

26. Polling Question #2

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Intelligent Data-driven Decisions
Paper-based
with manual
collection of
limited data
Data in multiple
legacy systems
with limited
visibility
Leveraging data
to optimize
processes
Unified and
connected
systems
provide greater
data visibility to
support
proactive
decisions
Leveraging
predictive
analytics for
intelligent
decision-making
and process
improvement;
integration with
functions related
to quality
REACTIVE TRANSFORMATIVE
Value Manual Managed Optimized Proactive Predictive

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Paving the Way for Analytics and Intelligent Decisions
Cloud Platform | Analytics
Business process
harmonization across GxP
Single unified quality
system
Enabling Technologies
Industry best practice data
model

29. Conclusion

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Summary
Industry Changes Are
Driving Transformation
Many Opportunities
for Quality
Enable Change with
Modern Solutions
Designed for
Life Sciences