Validation strategies for cloud-based EDCs: more innovation, less effort

Copyright © 2021,Bioforum
Validation strategies for cloud-based EDCs:
More innovation, less effort
April 2021

Tanya du Plessis
Vice President,
Data Strategies and Solutions,
Bioforum
Natalie Townsend
Senior Solution Consultant,
Vault CDMS,
Veeva
2

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3
Eat, Sleep, Innovate, Repeat
? ?
? And where do I
find the time to
validate?
And then stay
validated?
But what needs
to be validated?

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4
A Regulatory Requirement
The sponsor is ultimately responsible for the validation
of the computerised system and for providing adequate
documented evidence on the validation process.
EMA, Notice to sponsors on validation and qualification of computerised systems used in clinical trials

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Why Is Validation So Critical?
“Failure to document and therefore demonstrate the validated state of
a computerised system is likely to pose a risk to data integrity, reliability
and robustness, which depending on the criticality of the affected data
may result in a recommendation from the GCP inspectors to the CHMP
not to use the data within the context of an MAA”.

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6
Why Is Validation So Critical?
“Failure to document the validated state of a computerised system
poses a risk to data integrity, reliability and robustness, which
depending on the criticality of the affected data may result in a
recommendation from the GCP inspectors to the CHMP not to use the
data within an MAA”.

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What Are The Typical Pitfalls?
Just checking a box
•Overlooking the
importance
•Overlooking the
complexities
Overdoing it
•Try to validate
EVERYTHING
•Disregarding ALL
vendor evidence
No scope
•Failure to define the
correct strategy and
scope (e.g. validate
modules that are
not being used)
Under estimating
•Not having the right
resources available
•Not having a project
plan and timelines

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8
Validation Testing
8
Two Ways to Validate
Validation confirms that a system meets the user’s intended use of the system.
Perform testing yourself for each
of your user requirements
1.
Provide evidence (documentation)
that your requirements have been
met through the vendor’s testing.
2.

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Validation Testing
9
1) For each user requirement:
• Write a test script
• Perform data setup in a test environment
• Execute the test, following test documentation best practices
• Log any deviations from expected results and re-test as needed or
document work-around
• Sign-off on the test
1. 2.

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10
Validation Testing
10
2) For each user requirement represented in the vendor’s csv documentation:
Document the vendor’s ID for the most recent execution of a test for that requirement.
1. 2.

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Defining A Successful
Validation Strategy
Where to start?

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Validation Success
• Keep a record of what you have and have not done, understand what you
have so it is straightforward to reference
If it’s not documented
it didn’t happen
• Plan process and associated tasks and assign timelines
• Ensure there is a team available to execute (not as a side-line activity)
It’s a project not a task
• Get help when needed
• Prevention of rework and/or awkward questions from an auditor
No assumptions
• Plan for the next version upgrades from the beginning
Understand version
update processes
• Work with vendors that know the process, what needs to be in place, and
their responsibilities
Involve the vendor

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13
Vault CDMS Validation Approach
Software Quality Testing
Performed & Maintained by Veeva
PLC - Design, Unit Test, Build
Infrastructure
Specification
Hardware Quality Testing
Business Requirements
Document (BRD)
Software Quality Testing
Customer-Specific
Customer-Specific Application Configuration
Performed by Customer Project Team, consulted with Veeva
-User Requirements Spec (EDC System Req’s)
-Configuration Requirements Spec (VDS)
System Qualification
-User Acceptance Testing
-Configuration Verification
Study Design
Specification
Performed by Customer Study Team
Traceability
Study
Project
Product
Study Build
IQ
PQ
OQ
Study Design Verification
User Acceptance Testing
Study Qualification
Veeva validates
that the software
has been built per
our business
requirements
The customer must
validate that the
solution works per
their intended use
Each study must be
verified as meeting
study requirements
System
Validation
Study
Qualification

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14
Veeva Compliance Docs
Provides self-service access to
Validation Documentation, across
all releases and Veeva Products

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15
Validation Essentials
Processes
Performance
Qualification (PQ)
Defines the
specific business
requirements for
the system
User
Requirements
Specification
Outlines the
testing activities
and the test
scripts that will
be executed to
verify the
business
requirements for
configuration of
the system
PQ
Protocol
Defines the
objectives of the
validation
exercise and
activities, and
procedures and
responsibilities
for
accomplishing
those objectives
Validation
Plan
Validation Preparation
Processes
Performance
Qualification (PQ)
Summarizes all
activities
associated with
the validation
exercise,
including results
of testing
defined in the
UAT/PQ Test
Plan
Validation
Summary
Report
Validation
Completed
Val Summary
Provides linkage
between the
system
requirements
captured in the
URS and the
associated
UAT/PQ tests
that were
executed to
confirm those
requirements
Traceability
Matrix
Provide detailed
test procedures
and instructions
on how to
execute the
specific test
functions
defined in the
UAT/PQ Test
Plan
PQ
Scripts
UAT
Start
UAT
End
UAT

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16
16
Maintaining A Validated State
• Draft Release Impact Assessment
• Customer Release Preview Webinars
• Pre-Release Vaults Available
• Release Impact Assessment

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17
Feature Enablement Detail
17

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18
Validation & Innovation
18
Before
Release
Step 1
Prepare for
Auto-On Features
Step 2
Adopt new
Configurable Features
Stay
Validated
Obtain
Maximum
Value
After
Release
Strategy Objectives

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Teaming for Customer Success
19

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20
Looking To The Future
Embarking on a new
strategy/journey to
compliment your
current process
Thinking
Ahead

Thank you very much
Q&A

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22
20 May, 2021
Register now
Summit Connect is where the life sciences
community gathers to learn and exchange
knowledge.
This year, more than 2,000 R&D and Quality
experts will come together for a day of
collaboration and innovative discussions.

- Confidential -
23
20 May, 2021
Register now
Summit Connect is where the life sciences
community gathers to learn and exchange
knowledge.
This year, more than 2,000 R&D and Quality
experts will come together for a day of
collaboration and innovative discussions.
Clinical
Operations
Drive trial efficiency with a
unified and connected clinical
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Clinical
Data
Breaking from tradition to drive
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Regulatory
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A proactive approach to Quality
Management
Safety
Safety transformation with a
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Platform
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Validation strategies for cloud-based EDCs: more innovation, less effort

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