To get the full webinar, please visit: bit.ly/VaultTraining_2019_SlideShare Presented by the Veeva Quality Team and John Constantine of Orchestrall, Inc. Learn more about Veeva Vault Training, a new cloud application to simplify role-based training across life sciences organizations and help quality teams remain audit-ready and compliant: www.veeva.com/products/vault-training As life sciences companies transition from development to commercialization, they acquire new training systems to meet specific, short-term business needs. Managing multiple solutions quickly becomes difficult, introducing lots of manual overhead and compliance risks. With innovative cloud technologies, organizations can easily support complex training requirements and improve end user compliance with fewer – or even – a single system. Learn how to: Deliver compliance-based applications with greater efficiency Support blended roles and enable a more succinct learner experience Ensure compliant training records and reports in one place Provide traceability of the development and delivery lifecycle for all training materials To get the full webinar, please visit: bit.ly/VaultTraining_2019_SlideShare About Our Speakers: John Constantine, Orchestrall, Inc. John is a veteran of 30 years in the life sciences industry where his expertise lies in the application of learning to business strategy to drive workforce effectiveness and the application of technology to learning to drive learning effectiveness and efficiency. John s a long-term member and served on the Board of Directors of the Life Sciences Trainers and Educators Network (LTEN) for 14 years, including 2 years as president. Kent Malmros, Veeva Systems Kent has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at industry leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now at Veeva Systems.

1. 1Copyright © Veeva Systems 2019
Simplifying Training
in a Complex World

2. 2Copyright © Veeva Systems 2019
Disclaimer
This presentation is for informational purposes only and does not
constitute legal or other professional advice. You should consult your
own legal or compliance team before making a compliance decision.
All information is provided “as is”, with no guarantee of completeness,
accuracy, timeliness or of the results obtained from the use of this
information, and without warranty of any kind, express or implied. In
no event will Veeva be liable to you or anyone else as a result of your
use on this information.

3. 3Copyright © Veeva Systems 2019
John Constantine
ORCHESTRALL
John is a veteran of over 30 years in the life
sciences industry, first at GlaxoSmithKline, then
at Merck as Executive Director, Merck
Polytechnic Institute in 2008, and joining
Orchestrall, Inc. as Senior VP, Learning & Talent
Solutions in 2016. His background includes
Sales, Marketing, Corporate Staffs, Information
Technology, Research and Development, and 25
years in Learning & Development.
VEEVA SYSTEMS
Kent has spent the majority of his career
delivering technology-enabled training solutions
to life sciences, holding leadership positions at
industry leading companies such as AdMed,
ClearPoint (Red Nucleus), UL EduNeering (UL),
and now Veeva Systems.
Kent Malmros

4. 4Copyright © Veeva Systems 2019
What is
Digital Learning?

5. 5Copyright © Veeva Systems 2019
Digital Content
Documents, Video, eLearning
Systems that Support Both
Authoring Tools, LMS, and Everything Inbetween...
Digital Records
Assignments, Completions, Structured Data
What is Digital Learning?

6. 6Copyright © Veeva Systems 2019
Types of Tools
• Publishing
• Multimedia
• Rapid Authoring
Building DeliveringManaging
• DMS
• CMS
• Fileshares
• LMS
• Email
• Classroom

7. 7Copyright © Veeva Systems 2019
Types of Tools
• Publishing
• Multimedia
• Rapid Authoring
Building DeliveringManaging
• DMS
• CMS
• Fileshares
• LMS
• Email
• Classroom

8. 8Copyright © Veeva Systems 2019
Integration GxP LMS HR LMSDMS
Controlled documents
for quality and GxP
training needs
Manage GxP content and
its assignment to users,
as well as status
Sync between DMS
lifecycle states and
actions in an LMS
…
Additional LMS most
often used to assign and
track other content
…
Types of Tools

9. 9Copyright © Veeva Systems 2019
A system used to create and manage the lifecycle of
training materials for blended learning. Primarily used to
centralize learning content, for easy search and re-use.
An e-learning content authoring tool is a software
package which developers use to create and package e-
learning content deliverable to end users.
An application used to help manage training resources.
They are mostly designed to handle all the back-office
tasks associated with running training sessions.
An application used to offer online training to learners.
Not only does it allow you to offer eLearning content, but
it allows you to track and report on the learning.
An integrated suite that addresses recruitment;
performance management; learning and development;
and compensation management (the four pillars).
eLearning
Authoring Tool
Learning
Content
Management
Training
(Resource)
Management
Learning
Management
Talent
(Human Capital)
Management
Learning Technology Landscape

10. 1111Copyright © Veeva Systems 2018
• System of “Record”
• Completion vs. Consumption
• Compliance Impacts
• “Workaround” Culture
Focus on the LMS

11. 12Copyright © Veeva Systems 2019
Key “Digital Learning” Takeaways
LMS Harmonization is absolutely the first
place to focus. Learner records drive the
first line of compliance defense.
It’s not just about implementation,
administration or maintenance
efficiency. Where can business
process improve?
Examine connected systems and see where
you can move technologies into the cloud
for easier, modern unification or
integration.

12. 13Copyright © Veeva Systems 2019
The Single
System Conflict

13. 14Copyright © Veeva Systems 2019
One Problem, Three Perspectives
• SOP & Policy training (role-based)
• Part 11 compliant eSigs
• Qualification and Compliance
• Validation required
• Reporting emphasis
• First training adoption
GxP Training HR TrainingCommercial Training
• Mobile friendly (includes offline)
• Engagement-focused
• Launch and field readiness
• Content-types expand
• Compliance burdens change
• Validation not necessary
• Learning paths and competency
• L&D orientation
• More aligned with commercial
• Overlap with compliance
• Often own eLMS
• HR-integration focus

14. 15Copyright © Veeva Systems 2019
The Growth Trajectory
• LMS for GxP content
• LMS for non-GxP functional content
• LMS for HR content
• Mobile device delivery platform
• Live online – multiple platforms
• LMS for CIA remediation
• Coaching platform
• CRM training platforms
Controlled
Document
Training

15. 16Copyright © Veeva Systems 2019
Why Training Fragments
Different content, delivered in different media types, organized
by roles throughout different parts of the organization.
EDMS
GxP
LMS
CTMS
HR
LMS
Meeting
App
Skype
Web
CRM Coaching
Tool

16. 17Copyright © Veeva Systems 2019
Current State: Learning Delivery
Master
Control
Compliance
Wire
Veeva VaultSkillport
LERN.com
Webex
• Multiple assignment sources
• Multiple sources to find records
• No master location for SOPs, courses, and curricula
• Limited or no mobile device learning
• Static courseware, large volume, big ‘chunks’
Classroom
SharePoint Brain Shark
Others?
More being
discovered

17. 18Copyright © Veeva Systems 2019
Future State: Learning Delivery
Current State: Learning Delivery Future State: Learning Delivery
Master
Control
Compliance
Wire
Veeva Vault
Skillport
LERN.com
SharePoint
Webex
Classroom
3D Live
Just-in-Time
Mobile Microlearning
Others
• One place for ‘Learning’
• One place for ‘Records’
• One place to ‘Know’
Master
Control
Compliance
Wire
Veeva VaultSkillport
LERN.com
Webex
Classroom
SharePoint Brain Shark
Others?
Learning
Portal

18. 19Copyright © Veeva Systems 2019
Key “Single System Conflict” Takeaways
The product development lifecycle and
corresponding growth of a company will
dictate where “mature” training systems ar
first implemented.
Emphasize the strategic benefits of
a single master training record for
your organization to leverage data
fully.
Understand the impact of validation on
various learning systems and build
consensus around your guardrails.

19. 20Copyright © Veeva Systems 2019
Challenge
of Inertia

20. 21Copyright © Veeva Systems 2019
The Inertia Problem
• Inertia can be broken
without doing the full formal
system rationalization
• Hard to go from “many
to few”
• The fewer the better (one if
possible)

21. 22Copyright © Veeva Systems 2019
The Inertia Problem
• If you pick the right system,
you have more flexibility of
integrating some of the new
delivery methods.
• But once you get to one,
you have to make specific
decisions (can’t leave it to IT
or HR, has to be enterprise-
wide ownership and view)

22. 23Copyright © Veeva Systems 2019
The Problems with Fragmentation Inertia
• Manual Overheard
• Swivel Chair Systems
• Integration Upkeep
Process
Inefficiency
Learner
Confusion
Non-
Compliance
• Training Misses
• Reporting Challenges
• Timing Conflicts
• Multiple Interfaces
• Search Challenges
• Limited Content

23. 24Copyright © Veeva Systems 2019
The Impacts of Inertia
• Internal quality events with
training impact
• CAPA process oversight
• Chasing your tail
Investigation
Findings
Overall
Impact
Warning Letters
and 483s
• Inspections with training non-
conformance lead to advisory
actions by FDA
• 483 lists specific observations
• Easy to demonstrate compliance
• Potential for large fines and
business interruption
• Inefficient business processes
• Questionable product quality

24. 25Copyright © Veeva Systems 2019
Reasons for a Solution
Systems to launch, catalog, and track training should be
rationalized to a single platform for all content. Then we
must integrate the single LMS with the multiple delivery
systems so users at least perceive there is one place to learn,
one place to know, one place to find records.
Controlled
Content
Structured Data
and Workflows
Role-based
Qualification

25. 26Copyright © Veeva Systems 2019
Key “Single System Conflict” Takeaways
Identify the forces of inertia in your
organization and be the leader that ensures
they are “owned” by the right people.
Does inertia of related or
connected systems contribute to
the inertia around your LMS? Get
clarity on that point.
Be sure to point out where fragmentation
inertia creates compliance risk. This is the
most strategic way to combat it.

26. 27Copyright © Veeva Systems 2019
Overcoming
Complexity

27. 28Copyright © Veeva Systems 2019
Harmonization Case Study
Situational Overview:
Company had approximately 90 LMS products
Key Factors:
Learner non-compliance, risk in fragmented systems
Decision:
Consolidate to one LMS
Outcome:
~$10mm projects, successful harmonization
Key Lessons Learned:
Success, but the larger ecosystem still had work to do

28. 29Copyright © Veeva Systems 2019
Harmonization Economics
Typical Scenario Desired Scenario
= Point of diminishing returns on training volume

29. 30Copyright © Veeva Systems 2019
Harmonization Economics
Typical Scenario Desired Scenario
Difference in value
is influenced by
company decisions

30. 31Copyright © Veeva Systems 2019
Harmonization Economics
Typical Scenario Desired Scenario
Stopping at the
Apex is based on
company decisions

31. 32Copyright © Veeva Systems 2019
Practical Steps
To Harmonization
Modern System
• Multiple LMSs
• Content Storage and
Management
• Authoring Approach
Root Cause Use of LRS Right Altitude
• Adopt a new standard
• Bridge the gap
between chaos and
harmonization
• Software that brings
it all together
• Unification vs.
Integration
• Executive Level
Signoff vs. Active
Sponsorship
• The “Doers” to both
implement and
maintain
• Initiate vs. Maintain
• Ready, Set, Start

32. 33Copyright © Veeva Systems 2019
Key “Overcoming Complexity” Takeaways
Examine modern systems with an eye
toward native unification, then ease of
integration.
It’s not about today. It’s about
ensure compliance for the future.
Develop mastery of the economics (TCO,
support, validation, etc.) to make your case
of harmonization.

33. 34Copyright © Veeva Systems 2019
John Constantine
john.constantine@orchestrallinc.com
Kent Malmros
kent.malmros@veeva.com

34. 35Copyright © Veeva Systems 2019
Veeva Vault Training
Learn how you can easily ensure job or role-based readiness
ROLE-BASED
ASSIGNMENTS
END-TO-END TRAINING
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ENFORCE
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