Learn what inspectors are looking for and how to prepare for inspections in eTMF. This deck will cover an inspections overview, inspection preparation, inspector access, and inspection readiness. For more info, visit http://bit.ly/VaulteTMF

2. Inspections in eTMF
Presenter: Mark Romano, Veeva

3. 3Copyright © Veeva Systems 2018
Contents
Inspections Overview1
Inspection Preparation2
Inspector Access3
Inspection Readiness4

4. Inspections Overview

5. 55Copyright © Veeva Systems 2018
Medicines and Healthcare products
Regulatory Agency (MHRA) /
European Medicines Agency (EMA)
MHRA/EMA prefers to perform
inspections inside the source
application/system and expect:
• Training to last no more than 20
minutes
• To be unsupervised
• System should not increase
time/effort to perform inspection
US Food and Drug Administration
(FDA)
• The FDA inspectors do not directly
access electronic TMFs
• Inspectors typically have a
sponsor/CRO team member
navigate the eTMF
• Occasionally request a printout
and/or electronic copy
• Recent reports of FDA inspectors
accessing systems like MHRA/EMA

6. 6Copyright © Veeva Systems 2018
Inspector User Requirements for TMF
*MHRA GCP TMF workshop. The Royal Armouries Museum, Leeds, UK. September 5. 2017
What an inspector needs/expects*
TMF INDEX
DIRECT/CORRECT
ACCESS
SIGNPOSTS
TMF PLAN AND
PROCESS DOCS
eTMF EXPERT
SHORT TRAINING
AUDIT TRAILS
EASY NAVIGATION
AMPLE SPACE

7. 7Copyright © Veeva Systems 2018
Our Customers’ Experiences
Experience varies dependent on inspectors
Metrics on completeness, quality, and
timeliness
Inspectors request a report to show when
documents are created within eTMF

8. 8Copyright © Veeva Systems 2018
Document
upload timing
Uploaded and
finalized in timely
manner, e.g., 30 days
from receipt
Document
upload graph
Looking for trends
(spikes and troughs) in
the uploading of docs
Document
efficiency data
Shows timeliness in
document processing,
e.g., QC or approval
reports
What Inspectors are Looking for
Slide 1 of 2
Contemporaneousness

9. 9Copyright © Veeva Systems 2018
How quality is
managed
Trends in errors
or poor quality
What Inspectors are Looking for
Slide 2 of 2
Quality

10. 10Copyright © Veeva Systems 2018
Slide 1 of 2
Inspections – Being Prepared
Ensure you have an SOP/work instructions to guide you
Access Appropriate
setup
Reports
Prepare reports,
custom views,
export all study
content for
inspector’s use
Ensure appropriate
level of access
• Dedicated
inspector room
• Interview room
• Staging (“war”)
room for
briefings

11. 11Copyright © Veeva Systems 2018
Slide 2 of 2
Inspections – Being Prepared
Additional tips
Inspectors may ask for
a full audit report
Contemporaneousness
is not clearly defined
If compliant with
your own SOPs,
there should not be
a finding
• Explain volume of
data involved
• Discuss exact
needs and provide
specifics in a report

12. Inspection Preparation

13. 13Copyright © Veeva Systems 2018
What is Inspection Preparation?
Activities that occur when an inspection is announced
e.g., communication to appropriate sponsor and/or CRO personnel, notifying any other
relevant vendors, etc.
Activities performed before, during, and after inspection, including:
System setup
Activities supporting inspection

14. 14Copyright © Veeva Systems 2018
Slide 1 of 2
System Setup
Run a report?
Download documents?
How to deliver training? What
content should be included?
How can inspectors view/find
documents?
When can inspector access,
e.g., only onsite, weeks
before/after inspection?
Can inspector access eTMF
from own computer?
What can an inspector do in
eTMF?
Define process for granting
inspector access (create
user account) to eTMF
Inspector Training

15. 15Copyright © Veeva Systems 2018
Slide 2 of 2
System Setup
Issues and activities tracking log
War room support during
inspection
Use signposts/trackers to ID
content location and how to access
Process for retrieving documents
should be in place
If TMF documents not in
one location
Based on study, study country,
and sites requested
Recommend access be restricted
to final documents only
Process for granting access
to documents
`
Have seen companies
prepare inventory report
and/or classification content
map
Provide TMF index

16. 16Copyright © Veeva Systems 2018
Activities Supporting Inspection
1 2
Establish inspection
team
- QA lead
- IT lead
- Business lead
- Business support team
Execute inspection
process for:
- Inspector training/access
- War room support,
issue/action log tracking
- Daily closeout meetings
- Inspection debrief
- Management of findings

17. Inspector Access

18. 18Copyright © Veeva Systems 2018
Inspector Access
1
During an
inspection,
inspectors can be
trained and granted
access to eTMF
Inspectors are
typically only
granted access to
documents which
meet the scope of
the inspection
The process for
setting up inspector
access should be
documented in a
SOP or WP
4
The setup process is
often done in
advance so eTMF
access can be
granted once
inspectors are
trained
5
Consideration must
be given to security
configuration, e.g.,
user access, roles,
permissions
2 3

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Considerations for Inspector Access
The inspector should be granted access to all final documents and any other documents to
fully evaluate the clinical story represented by the TMF in accordance with the defined
business process
- Access to non-final documents not recommended
The TMF plan should clearly state how the TMF is organized and how it will be used
- File structure (e.g., according to TMF Reference Model)
- Roles and responsibilities
- Timelines
- Archive process

20. Inspection Readiness

21. 21Copyright © Veeva Systems 2018
Every document
included in eTMF has
been checked for
quality and content at
the time of its
creation/upload
All documents/select
documents have been
checked against other
related documents at
predefined points
(e.g., milestones)
according to the TMF
Plan
Key Concepts
Inspection readiness is a state of being, not a preparation activity
What is an inspection-ready eTMF?

22. 22Copyright © Veeva Systems 2018
Accuracy
• Attributable, Legible,
Contemporaneous,
Original, Accurate
(ALCOA)
• All content is correct
and tells the full
story
Timeliness
• Documents are not
delayed getting into
the TMF
• Avoiding last minute
uploads and
document approvals
Completeness
Including systematic
checks to ensure all
expected documents are
present, including event
driven changes, e.g.,
protocol amendment
Defining Inspection Readiness
Inspection readiness is a state of being, not a preparation activity
Quality metrics drive business processes
Business process needs to be clearly defined
eTMF alone does not make you inspection ready
Must integrate clinical trial and TMF processes (real-time TMF management)

23. A Quality by Design Approach
to Inspection Readiness

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A Quality by Design Approach
• A concept first outlined by quality expert
Joseph M. Juran
• Designing for quality and innovation is one
of the three universal processes in which
Juran describes what is required to achieve
breakthroughs in new products, services,
and processes
• Belief that quality could be planned and
most problems relate to the way quality was
planned
Pharmaceutical Quality by Design
(QbD)
• In recent years, the agency has implemented
QbD concepts into its pre-market processes
• Quality should be built into a product with an
understanding of the product and process by
which it is developed and manufactured along
with a knowledge of the risks involved in
manufacturing
• Attempts to provide guidance to facilitate
design of products and processes that
maximize product efficacy and safety while
enhancing manufacturability

25. 25Copyright © Veeva Systems 2018
Quality by Design Process Elements
1
In-line document
QC checks
• Built-in
workflows
• Accuracy and
timeliness
Comprehensive
TMF QC checks
• Reporting and
document fields
• Completeness
and accuracy
Performance
monitoring
• Reporting and QC
matrix
• Completeness
42 3
A Quality by Design approach means incorporating certain TMF quality
procedures into an organization’s overall clinical development process
Resolution of
issues
• Process for
documenting and
resolving findings
that have been
identified

26. Thank you