Veeva Systems Webinar: Driving Continuous Quality Improvements

Driving Continuous Quality
Improvements

Vice President, Vault Quality
Mike Jovanis

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Copyright © Veeva Systems 2021
Industry trends and their impact on quality
Drivers for modernizing quality systems
Modernization opportunities
Summary and next steps
Q&A
Agenda

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The Industry Has Changed
Globalization &
Externalization
• Quality processes extended to
partners, yet systems are only
internally accessible
• Continued globalization of
supply chain
• Lack of global visibility across
internal and external quality
Increasing
Complexity
• Necessity of working virtually
across geographies
• Achieving speed and agility is in
conflict with complexity
• 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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Drivers for Modernizing Quality Systems
Agile Digital Systems in Quality
Cloud • Mobile • AI
Connected end-to-end
processes
Third-party collaboration
within quality systems
Shift toward proactive quality

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Quality Systems Landscape Today
…and how we got here
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 time
• Increasing cost and
complexity based on
compliance issues and
individualized
investments
Time
Investment
Transformative Investment
Incremental Investment

Opportunities to Modernizing
Quality Systems

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Industry Shift Requires Different Perspective / Thinking
Incremental Investments
Fragmented landscape
Transformative Projects
Singular, global quality projects
True Shift to the Cloud
Different TCO footprint
Opportunity for Value
Broad opportunity for business
process efficiency and
connected business processes

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Opportunities for Modernizing Quality
Digitization of
quality content
Unifying and
connecting
quality processes
Improving third-party
collaboration with
quality systems
Enabling proactive
quality management
with advanced
technology/AI

Digitization of Quality Content

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Digitization of Quality Content
Collaborative
Authoring
Mobility
on the Shop Floor
Paperless
Protocol Execution
Process-centric
Content Navigation
Video-based
Content Delivery
Digitization
of Training Matrix

Unifying and Connecting Quality
Streamlining business processes within quality and
across business functions

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End-to-end Product Technical Complaint Process
Medical Inquiry/
Inbound Product
Complaint
Complaint
Handling
Change
Control
Regulatory
Approval
MLS/Med Affairs Complaint Handler Change Owner/Mfg. Reg Ops
ROLE
INTEGRATIONS Call Center, Veeva CRM ERP PLM / ERP ERP

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Streamlining Change Control
Quality
Event
Implementation Actions
Regulatory Actions
Document Change Control
CAPA
Change
Control
Automated Re-Training
Qualify by
Role
Better
Intelligence
Seamless
Process
Accurate
Product
Releases

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Content Updates Fully Unified into Change Process
• 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 Regulatory
QUALITY
REGULATORY
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

Improving Third-party
Collaboration
Bringing Suppliers and Partners within Quality Systems

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Providing Access to Suppliers
Then and Now
Purchase
additional
software products
Attempt training
external users on
legacy systems
Manage
complex
security
Configure
complex VPNs
and firewalls
Integrate additional
products to legacy
system Configure Security and
Access Privileges
Legacy Systems Modern Cloud
X
X
X

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

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Supplier-centered View of Quality
Unified and regimented supplier quality across landscape
of vendors
Direct supplier engagement in relevant processes
Secure document exchange
Optimization of quality resources against higher-risk
vendors
Audits and supplier quality issues linked directly to each
supplier
Holistic view of supplier quality management with
intuitive reports and dashboards
Qualification
Audit
Onboarding
Management
Retirement
Supplier Quality
Management

Enabling Proactive Quality
Management
With Advanced Technology/AI

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AI Technologies and Their Objectives
Autonomous
Intelligence
Augmented
Intelligence
Assisted
Intelligence
Automated
Intelligence
ADVANCED
Robotic Process Automation
(RPA)
Intelligent Process
Automation (IPA)
Machine Learning (ML)
Natural Language Processing
(NLP)
Computer Vision
Automation of
manual/cognitive and
routine/non-routine tasks
Helping people to perform
tasks faster and better
Helping people to make
better decisions
Automating decision
making processes without
human intervention.
• Triaging and routing
• Intelligent integration
• Duplicate detection
• Risk identification
• Auto-classification
• Auto-linking
• Risk Recommendation
• Issue/signal detection
• Pre-empt process
blockages
TECHNOLOGY
VALUE
USE
CASES
BASIC

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The Current State of AI in Quality
Lack of foundational,
shared understanding
Hype coming from
multiple sources
Promises to deliver a
large impact

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AI Myth vs. Reality in Quality
AI will magically deliver the right intelligence on
day 1
Success requires a long-term strategy combined
with best-in-class processes and systems
AI fixes data issues and process inefficiencies
High-quality contextual data is key to gaining value
from AI investments
AI will replace humans
AI assists humans to perform tasks more
effectively and efficiently
X
X
X

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AI Continuum
Application Specific Cross-Application
• Delivered by application vendors
• Contained
• Focused
• Embedded
• Specialized AI vendors
• Across application spaces
• Broad
• External

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Quality Event
Recurrence Check
Efficient and sophisticated way to
check for recurrences
Use of advance technologies for
automated matching
Key Concepts
• Ability to support automated check for similar or recurring events
during record entry
• Matching based on structured and unstructured data using
advanced technologies (semantic NLP)
• Best matched results presented to user with similarity scores to
choose from
• Automatically relates similar events bi-directionally once
confirmed
• Feature effectiveness will continue to improve over time with
practical use

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Quality Bot
Robotic process automation for
complaint intake and triage
Targeted to reduce labor effort
and increase precision
Processing of inbound cases from multiple sources
Divides cases, categorizes, and routes based on pre-defined
criteria
Routing based on structured and unstructured data using
advanced technologies (semantic NLP)
Will learn and become more sophisticated with use
Applicable in diverse intake scenarios that span pharma and
medtech

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Laying the Right Foundation for Quality Transformation
1 2 3
Identify opportunities
for value generation
and efficiency
Simplify and
harmonize business
processes
Establish a strong
foundational data
model and migration
strategy to support the
use of advanced
technology.

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Summary
Industry Changes Are
Driving Transformation
Many Opportunities
for Quality
Transformation is
delivering value
Designed for
Life Sciences

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How can we help?
michael.jovanis@veeva.com
Michael Jovanis
Contact us
Learn more
www.veeva.com/quality

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Polling Question #1
What is your organization’s current quality system landscape?
A. Manual/paper-based processes only
B. Manual/paper-based processes with some technology
C. Multiple on-premises electronic systems for quality documents and processes
D. A mix of on-premises and cloud systems
E. Unified on a cloud platform

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Polling Question #2
What challenges does your organization face in streamlining quality processes? (Select
all that apply)
A. Aging systems with poor usability
B. Complex integrations across multiple applications
C. Document-based processes /lack of automation
D. Lack of visibility into various quality processes
E. Ineffective collaboration with suppliers/partners
F. Other

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Polling Question #3
My company’s existing systems allow me to easily collaborate with internal employees
and external partners.
A. Strongly agree
B. Somewhat agree
C. Strongly disagree

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Polling Question #4
What’s your organization’s current plan to use AI technologies in quality?
A. Actively using
B. In the process of implementing
C. Planning to implement in one or two years
D. No current plans

Veeva Systems Webinar: Driving Continuous Quality Improvements

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