In the life sciences, most of the documents we create end up as records. Now, as we move towards a paperless era in today’s GxP environment and leverage digital content management technology, we are also starting to change the way that we author, collaborate, manage, exchange, and archive our documents. The very nature of document management is transforming as more and more data becomes part of the document management landscape. In this webinar, we explore how technology is transforming our GxP records management environments and what the future may hold for automating processes

2. Tech Spotlight:
Automation of
Document
Management
Webinar
June 6th, 2019

3. House Keeping
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4. 4
House
Keeping
L I V E W E B I N A R
• This webinar is being recorded and
will be made available after this
session
• Feel free to use the chatbox to
submit your questions at anytime
• Q&A will take place at the end of
the webinar

5. 5
Meet Your
Speaker
Paul Fenton
President and CEO,
Montrium

6. • Founded in 2005
• Working Exclusively in the Life Sciences
• Headquartered in Montreal, Canada
• EU HQ in Brussels
• Clients in North America, Europe & Asia
• Leading Content Management Platform
• Over 8000 Users in 20+ Countries
• Experienced Professional Services Group
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About
Montrium
Connecting People,
Processes & Technology
A B O U T T H E C O M P A N Y

7. 7
Electronic Content
Management & Business
Intelligence for Clinical
Trials
C O N N E C T P L A T F O R M
Regulatory Document
Management & Submission
Planning for Drugs and
Devices
Integrated and Data Driven
Quality Management
Solution for Life Sciences

8. In the life sciences, most
documents we create
end up as records
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9. England, 1086….

10. What is a record?
A thing constituting a piece of
evidence about the past, especially
an account kept in writing or some
other permanent form
-Oxford English Dictionary

11. v
What is a GxP Record
There is no clear universal definition but…here’s an
example….
Information related to an activity subject to GMP
regulations and required by the GMP regulations
to be retained as historical evidence of the activity
and/or to support quality, compliance, safety and
efficacy of the product

12. Automation Can Help!

13. A Brief history of document/record
management Innovation
3500 BC
The Sumerians
First Steps
1898
Edwin Grenville Seibels
invents the filing cabinet
1925
George McCarthy
Checkograph
Machine
Permanent film
copies
of bank records
1960s
IBM
Mainframe
computer
1980s
Flatbed scanner
& OCR
1990s
The PC and
the Internet
Today
The cloud &
AI revolution…

14. What is automation?
To make a process in a factory or office
operate by machines or computers, in
order to reduce the amount of work done
by humans and the time taken to do the
work

15. The Olden Days
• Paper was king
• We collaborated via email or by passing
paper documents around
• It took for ever to get a document approved
• We stored everything (we think) in central
files
• I think it is on my C: drive somewhere...
• Metadata…what is that?

16. Poll Which of the following best describes your
document management situation?
a) We generate paper records and we store them in a
document room
b) We work on a file share and use email to collaborate
c) We have a document management system, but only
store final records there
d) We have a document management system where we
collaborate using workflows
e) We use stone tablets for our records management
f) I don’t produce or collaborate on documents
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17. Times are a
changing
• More and more we are using centralized
content management systems
• Documents are becoming data
• Standards are emerging
• The way we collaborate is evolving
• Email is disappearing
• Systems are becoming more intelligent
• People are becoming more tech savvy
• Paper is disappearing…

18. It not just
documents
any more…
• More and more systems are being
used in GxP environments
• Activities are documented more and
more in the form of data
• There is a strong focus from the
regulators on data and data integrity
• Activity logs and audit trails are
becoming more prominent
• Automation can help….

19. Axes of
Automation
Data &
Standards
Digital
Collaboration
Automated
Document
Recognition &
Indexing
Automated
Quality Control
and Review
Predictive
Analytics
Content and
Data
Interchange
and System
Interoperability

20. Data and Standards at
the heart of automation
• Automation is impossible without data and standards
• Data drives processes which allow us to automate
• We have a lot of standards for GxP data such as CDISC
• We have a few for documents such as eCTD and eTMF-EMS

21. Data and
Standards at
the heart of
automation
• Within a GxP context there is a strong
case for developing a standard
focusing on processes
• Ultimately this would allow for much
more automation within document &
records management
• There are also several promising
workstreams within Transcelerate
which could have a positive impact on
automation in the future:
- CPT
- Digital Data Flow

22. What is
Digital
collaboration
Digital collaboration is
using digital technologies
for collaboration. Dramatically
different from
traditional collaboration, it
connects a broader network of
participants who can accomplish
much more than they would on
their own
-Tapscott, Don (2006)

23. Today
everything
is digital
• We are starting to see tools that we have been using
socially creep into business application
• Workflows have been around for a while and traditionally
people have resisted them
• New more flexible tools and a different approach to
workflows which are more user driven is changing that
• Simultaneous document authoring and collaboration is
also another area which is changing the way we work
• Given the regulators focus on audit trails and activity logs
we need to carefully consider what activity information
we should retain as records...

24. Intelligent documents
Intelligent documents are typically forms that are separated into three layers:
Presentation Layer
Data Layer
Business Logic Layer
Formatting and Layout
Structured data or metadata
Rules and Validation / interactions with
workflows

25. Intelligent documents - Benefits
• Can be especially useful when creating mass documents such as DILs,
1572s, Financial Disclosures etc.
• Improves the quality and completeness of information contained within the
documents due to validation rules
• Can leverage 3rd party data sources to provide values
• In some case can automatically populate metadata in EDMS or populate
databases with data
• Can trigger workflows and automated business processes based on data
entered into intelligent documents
• Could be useful in the future when submitting structured records to the
regulators
• We should leverage this approach more as an industry…

26. Poll
Do you currently use intelligent
documents in your organization?
a) Yes
b) No
c) I don’t know
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27. Interchange and
interoperability -
A big challenge in todays
GxP environment

28. • Often many different systems are used within GxP activities
• These systems are usually not integrated and are often dependent on
each others data
• It can be a big effort to integrate due to lack of common data
standards and data platforms
• Today, a lot of manual work is usually involved when moving content
between systems
• Efforts are underway to improve the ability to exchange data and
content in a more structured manner through development of
standards
• This will allow us to automate the exchange of information between
systems with minimal or no human intervention
• This presents a huge opportunity in terms of how we organize GxP
records and information in the future

29. • Manual document processing and
indexing can be expensive and
time consuming
• Using AI and Machine learning can
be leveraged to facilitate
and automate processing and
indexing
• This can be achieved using different
techniques including:
• OCR and metadata recognition from
keywords
• Document type recognition based on
document charateristics
• Improves over time
• Not 100% error free...yet…
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Auto
recognition
and indexing

30. Automated Quality Control and
Predictive Analytics
• Today we tend to manage quality and issue management manually
• By implementing data management type techniques to records management we
can start to automate this activity
• These techniques include:
• Batch and real-time anomaly detection using rules engines and historical data
• Detection of record inconsistency using predictive process models
• Identification of higher risks based on risk scoring algorithms
• By putting in place analytics and the above techniques we can focus our efforts
on making sure that we have adequate records to document our activities based
on computer generated targets

31. Archiving & continuous periodic review
• There is a case for using automation in archiving based on electronic
retention policies – this is already well established
• The bigger issue is maintaining the records in a compliant state over the
long retention period (25 years)
• More and more organizations are archiving on cloud based solutions
• These solution evolve over time and need to be maintained in a
validated state and records need to continue to be ALCOA+
• Automation can be used to maintain the long term archive in a validated
state by running programs on the environment to detect potential
changes and run automated tests to ensure ALCOA+
• We call this concept CVaaS (Continuous Validation as a Service)

32. Poll What do you consider to be the most
important benefit that automation can
bring to document management?
a) Improved quality of records
b) Reduce time to produce records
c) Reduced cost in producing and managing records
d) Better regulatory compliance and traceability
e) Quicker access to information
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33. In Summary…
• There is great potential to automate many of our document
creation and records management processes
• As technology and standards evolve automation will become
easier
• We need to find ways of ensuring automation is a help not a
hindrance
• Automation can help with providing traceability for
inspections and regulatory compliance...make sure you think
about this when automating processes

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• Facilitate exchange of clinical trial
information to all stakeholders
• Accurately track the progress of
TMF completeness
• Quickly comply with regulatory
requirements, audits and
inspections
An intuitive eTMF
Platform Engineered for
Growth Organizations

35. Are you interested in receiving
more information about
Montrium’s eTMF Connect?
1) Yes, could be useful
2) No, not interested
35
POLL

36. QUESTIONS?
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