The document provides an overview of Veeva's approach to simplifying postmarket surveillance for medical devices. It discusses the challenges companies face with current postmarket surveillance programs, including systems that have become too complex and difficult to use over time. Veeva proposes a unified postmarket surveillance solution on its cloud platform that incorporates best practices and standardized processes. Key aspects of the solution include unified complaint management, automated regulatory reporting, and tools to connect postmarket data to other quality management activities. The presentation explores how Veeva's approach aims to modernize postmarket surveillance and help companies more efficiently meet regulatory requirements.

1. Simplifying Postmarket Surveillance

2. 2Copyright © Veeva Systems 2020
Agenda
Veeva Overview1
Vault Quality Suite2
Postmarket Surveillance – A Preamble3
Overview, Industry Challenges & Topics for Consideration4
How Can Veeva Help?5
Q&A6

3. Veeva Overview

4. 4Copyright © Veeva Systems 2019
Vision
Building the Industry Cloud for Life Sciences
Values
Do the Right Thing
Customer Success
Employee Success
Speed

5. 5Copyright © Veeva Systems 2019
Founded in 2007 3,500+ Employees 165+ Countries850+ Customers
HQ in the San Francisco Bay Area, with offices throughout North America,
Europe, Asia, and Latin America.
Fastest Growing
Company Market Leader
#8 Fastest Growing
Public Tech Company
• Build innovative, cloud-based solutions for life sciences
• Provide implementation services for customer success
• Enhance customer value through a robust partner ecosystem

6. 6Copyright © Veeva Systems 2020
Veeva Spans an Entire Life Sciences Company
RegulatoryClinical
Operations Medical CommercialQuality Drug SafetyClinical Data
Management
Coding
EDC
Workbench
Study Startup
eTMF
CTMS
Payments
QMS
QualityDocs
Training
Station Manager
Product
Surveillance
Submissions
Subs Archive
Registrations
Publishing
Medical CRM
MedComms
Oncology Link
OpenData
Multichannel CRM
PromoMats
Nitro
Andi
Safety
SafetyDocs
Safety.AI

7. Vault Quality Suite

8. 8Copyright © Veeva Systems 2020
Unified quality management

9. 9Copyright © Veeva Systems 2020
Veeva Medical Device & Diagnostics Focus
More Than Just Software
People
Dedicated
Services
Product Customers
Veeva
Summit

10. 10Copyright © Veeva Systems 2020
About the Speaker
Carl Ning, Sr. Director of Strategy
Veeva Vault Quality | Medical Device & Diagnostics
• 20+ years of experience in life sciences, consumer products,
discrete manufacturing, and financial services industries
• 15+ years dedicated to quality management
• 100+ quality/regulatory system design and implementation
initiatives
Contact Information: carl.ning@veeva.com

11. Postmarket Surveillance
A Preamble

12. 12Copyright © Veeva Systems 2020
Perception Regarding Postmarket Surveillance
12

13. 13Copyright © Veeva Systems 2020Copyright © Veeva Systems 2019
Polling Question
•How well is your current
postmarket surveillance
(PMS) program meeting user
satisfaction, adaptability,
maintainability, and
throughput demands?

14. 14Copyright © Veeva Systems 2020
Our Objectives
Modern, best-of-breed complaint handling & adverse event reporting
capability on our enterprise-ready Vault platform
Standardized, delivered best practices to minimize effort while
maximizing implantation velocity
Product Surveillance capability unified within our Quality Suite and
connected to other functional suites across our platform

15. Postmarket Surveillance
Overview

16. 16Copyright © Veeva Systems 2020
Postmarket Surveillance
16
According to ISO 13485:2016, postmarket surveillance is
“a systematic process to collect and analyze experience
gained from medical devices that have been placed on the
market.”

17. 17Copyright © Veeva Systems 2020
Sources of Input
17
Postmarket Surveillance
Complaints
& Adverse
Events
Service
Records/
Reports
Literature
Reviews/
Scholarly
Publications
Surveys
Clinical
Evaluation
Reports
Customer
Discussions
Trade Show
Meetings

18. 18Copyright © Veeva Systems 2020
Sources of Input
Complaints, Adverse Events & Connected Quality Processes
Ensure trending of recurring NCs,
complaints, recommended
actions
A consistent response is required,
facilitated by a learning
environment
Monitor the progress of
complaints and customer
feedback
Efficient workflow? Right first
time? Right people assigned?
Implement complaint feedback –
escalation to CAPA or process
changes
Are you using information
effectively and efficiently?
Determine if actions taken are
adequate or if follow-up is
necessary
Verification of effectiveness?
Internal audits may also be useful
Ensure that all stakeholders are
notified of a complaint’s final
disposition
Effective notification of
progress/closure improves
perception
Monitor metrices for breeches or
spikes before they violate
thresholds
Don’t wait for problems to occur.
Monitor and take actions on
developing signals

19. 19Copyright © Veeva Systems 2020
Sources of Input
Complaints, Adverse Events & Connected Quality Processes
Ensure trending of recurring NCs,
complaints, recommended
actions
A consistent response is required,
facilitated by a learning
environment
Monitor the progress of
complaints and customer
feedback
Efficient workflow? Right first
time? Right people assigned?
Implement complaint feedback –
escalation to CAPA or process
changes
Are you using information
effectively and efficiently?
Determine if actions taken are
adequate or if follow-up is
necessary
Verification of effectiveness?
Internal audits may also be useful
Ensure that all stakeholders are
notified of a complaint’s final
disposition
Effective notification of
progress/closure improves
perception
Monitor metrices for breeches or
spikes before they violate
thresholds
Don’t wait for problems to occur.
Monitor and take actions on
developing signals
“A high volume of complaints doesn’t necessarily mean a
poor state of compliance. Its more about how you
monitor and respond to them.”
-Kim Trautman, Exec VP, NSF Medical Device & Regulatory Compliance, former Assoc. Dir, FDA/CDRH

20. Postmarket Surveillance
Industry Challenges | Design Considerations

21. 21Copyright © Veeva Systems 2020
The “De-evolution” of Complaint System Design
• De-evolution due to:
• Process design constraints
• Reactive adaptation to requirement
changes
• Complex, unnecessary
integration/automation decisions
• Diminished usability over time and
inability
Process re-
engineeringCustom reporting/
Integration to BW
RIM integration
Upgrade
challenges
Validation
Custom dynamic
forms
Custom intake/
CRM integration
Reliance on 3rd
party platforms/
applications
3rd party doc
management

22. 22Copyright © Veeva Systems 2020
Begin with the “Customers” of PMS Output
• FDA / Health Authorities
• Consistent & timely reporting
• Complaint investigation depth
• Capturing patient impact
• Design / product / engineering team
−Trending outputs
• Management
−Proper strategy; review cadence
Process re-
engineeringCustom reporting/
Integration to BW
RIM integration
Upgrade
challenges
Validation
Custom dynamic
forms
Custom intake/
CRM integration
Reliance on 3rd
party platforms/
applications
3rd party doc
management

23. 23Copyright © Veeva Systems 2020
The “Other” Syndrome

24. 24Copyright © Veeva Systems 2020
The “Other” Syndrome
Likely Causal Factors
How to Improve?
• Sub-optimal solution design
• Too many picklist values or field dependencies
• Confusing form design
• Potential training issue
• “Right-size” picklist values, field dependencies, and form
design
• Provide appropriate training
• Leverage dynamic forms, if available
• Monitor process to add or remove values

25. 25Copyright © Veeva Systems 2020
Multi-language Support & Good Design Practices
Structured static content like field names, picklist value, etc.
Ability to import/export content for additional language support
But what about free-text or unstructured data??

26. 26Copyright © Veeva Systems 2020
Multi-language Support & Good Design Practices
Not every free text/unstructured data needs to be translated
Utilize a “Doppelgänger” field where required
Internal resources or 3rd party translation solution provider??

27. 27Copyright © Veeva Systems 2020
Artificial Intelligence – An Evolving Continuum
• Near infinite applications
across multiple disciplines
• Still considered nascent
technology within quality
Duplicate, similar,
related quality
records, persons,
organizations
Risk categorization
recommendations
Suggested complaint
reportability
decisions
Postmarket Surveillance Use Cases

28. How can Veeva help?
Unified & Connected

29. 29Copyright © Veeva Systems 2020
Unified quality management

30. Modernizing Postmarket Surveillance
Vault Product Surveillance

31. 31Copyright © Veeva Systems 2020
Vault Quality – Medical Device & Diagnostics
SOPs and
Work Instructions
VAULT QUALITYDOCS
Specifications Test Data Other GxP Regulated
Content
Design History File
(DHF)
Supplier Contracts
and Agreements
Global Compliant
Reportability
Decision Tree
VAULT PRODUCT SURVEILLANCE
FDA eMDR EU MIR Non-electronic AER
Submissions
Voluntary
Malfunction
Summary Report
Dashboards | Metrics | KPIs
VAULT TRAINING
Quality Risk Management
Complaint CAPA
Audit
Management
Nonconformance
Change
Management
Supplier Quality
Management
Artificial Intelligence-based Features (e.g., related/similar/duplicate records, suggested reportability decision, incident auto-classification/codification,
risk & root cause recommendation)

32. 32Copyright © Veeva Systems 2020
Vault QMS Delivered Applications
• Challenge historical notion of rigor in up-
front requirements definition versus allowing
delivered application to influence thinking
− Vault QMS has a delivered foundational configuration
− Requirements definition should be done with
consideration to this foundation
• Delivered Application incorporates design
elements from Part 820 and ISO 13485
• Foundational design help maximize
implementation velocity
− Quickly differentiate between “nice-to-have’s” vs.
“must-have’s”
− Best practices design available for adoption, with
flexible configuration capabilities to meet customer
specific requirements
Product Return | Vault Surveillance | Correction | Containment |
Investigation | Root Cause Analysis (RCA)
Complaint Nonconformance
CAPA Change Control
CAPA Action | Change Action | Effectiveness Check |
Finding | Audit Action | Supplier Collaboration
Audit Supplier Quality
Mgmt
QualityRiskManagement
Dashboards|Metrics|KPIs

33. 33Copyright © Veeva Systems 2020
Vault Product Surveillance
• MedTech-optimized complaint handling and adverse
event reporting
• Fully automated electronic submission health
authority reporting + non-electronic submission
output
• Standardized global reportability decision tree with
event type specific reporting timelines
• Seamless addition to Vault Quality Suite
• Can also be used by companies with diverse product
mixes
• Planned availability to early adopters late 2020
Complaint Management
Correction | Investigation | Root Cause Analysis (RCA)
Quality Risk Management
Dashboards | Metrics | KPIs
Vault Product Surveillance
Global Complaint
Reportability Decision Tree
Non-electronic Submission
Adverse Event Reports
FDA eMDR EU MIR
Voluntary Malfunction
Summary Report (VMSR)
Periodic Safety
Update Report (PSUR)

34. 34Copyright © Veeva Systems 2020
Vault Product Surveillance
• Provides Adverse Event Reporting (AER)
management as a service
• Will continue to evolve and include additional
health authority/agency AER templates
• Health authorities/agencies with communicated,
final specifications for electronic submission (i.e.,
electronic payload generation, transmission, and/or
acknowledgement receipt process) would be
prioritized over non-electronic submission formats
for roadmap purposes.
Complaint Management
Correction | Investigation | Root Cause Analysis (RCA)
Quality Risk Management
Dashboards | Metrics | KPIs
Vault Product Surveillance
Global Complaint
Reportability Decision Tree
Non-electronic Submission
Adverse Event Reports
FDA eMDR EU MIR
Voluntary Malfunction
Summary Report (VMSR)
Periodic Safety
Update Report (PSUR)

35. 35Copyright © Veeva Systems 2020
Vault Product Surveillance – Reporting Timelines

36. 36Copyright © Veeva Systems 2020
Unified and Connected Quality & Beyond
Connect content updates to
change control
Leveraging RIM as system of record of countries marketed/where-sold data for added PMS efficiency
Greater visibility by quality teams into impact assessment and regulatory teams into change requests
Easily access training content
Connect CAPAs and change control to training
Vault Quality Suite Vault RIM

37. 37Copyright © Veeva Systems 2020
Improving User Ergonomics – Dynamic Forms

38. 38Copyright © Veeva Systems 2020
Improving User Ergonomics – Dynamic Forms

39. Optimizing Maintainability

40. 40Copyright © Veeva Systems 2020
Assess New Features

41. 41Copyright © Veeva Systems 2020
In Conclusion
End-to-end MedTech complaint management
on Enterprise-grade cloud platform
Standardized, delivered best practices to
accelerate implementation timeframe
Unified & Connected

42. 42Copyright © Veeva Systems 2020
Contact me to learn more about Vault
Product Surveillance and Vault Quality
Suite:
carl.ning@veeva.com
Website:
www.veeva.com/quality
Next Steps

43. Questions?

44. Thank you