Blockchain, IoT and the GxP lab technology helping compliance? This webinar discusses how distributed ledger technology like blockchain and IOTA could help enhance compliance in GxP laboratories. It explores how DLT could be used to track devices, materials, and data in a more transparent, trusted and auditable way. Specifically, it presents a vision of an internet-connected "laboratory of the future" where all devices share data using DLT. This could improve integrity, security and access to data while reducing costs. While DLT cannot directly increase compliance, it may help build trust in GxP systems and processes by making components more transparent to regulators.

1. February 13, 2019
Blockchain, IoT and the GxP lab
technology helping compliance?
Moderator: Jake Dreier – Pistoia Alliance
Panelists: Richard Shute - Curlew Research
Adrian Marks - Red Kite Projects

2. This webinar is being recorded

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Jake Dreier, Blockchain Project Manager, the Pistoia Alliance
➢ Pre-Blockchain Workshop Community of Interest Meeting: February 20th, 11am
EST/ 4pm GMT
➢ Blockchain R&D Use Case Analysis Workshop: March 12th, Hilton London
Paddington

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The Panel
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Adrian Marks, Iota Advocate, Red Kite (Iota) Projects, Ltd.
Adrian has always operated at the intersection between technology and business. In a
career that spans major corporates, consultancies and technology businesses. He
currently spends part of his time as a Director of Business Development for Bluesmith
Information Systems, a specialist in software and data engineering projects. He also runs
a technology consultancy business, Red Kite Projects Ltd, where he focuses on
researching & understanding disruptive technologies. He has a particular interest in
Distributed Ledger Technologies & acts as a Community Leader for IOTA, a new
transaction settlement and data transfer layer for the Internet of Things (IoT).
Richard Shute Consultant Curlew Research
Richard is an accomplished IS/IT strategic business relationship, account and portfolio
manager, medicinal chemist, scientist and thought leader, with over 25 years of
experience in the pharmaceutical industry. Richard is a Consultant for Curlew Research
and has blogged extensively on the role of blockchain tech in life sciences. He was
project manager for the Pistoia Alliance work on “Blockchain Applications to Life
Sciences R&D” from March-December 2018.

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Poll Question 1
• What is your familiarity with blockchain?
A. I am using blockchain
B. I am experimenting with blockchain
C. I am aware of blockchain
D. I know next to nothing about it

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Poll Question 2
• What is your organization’s familiarity with
blockchain?
A. Actively using blockchain
B. Experimenting with blockchain
C. Aware of blockchain
D. Not sure about my organization

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Blockchain, IoT and GxP – Distributed
Ledger Technology helping compliance?
A wealth of opportunities
Richard Shute
Curlew Research

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What is “blockchain”?
• Blockchain technology offers a way for
untrusted parties to reach agreement
(consensus) on a common digital history.
• A common digital history is important because
digital assets and transactions are in theory
easily faked and/or duplicated.
• Blockchain technology solves this problem
without using a trusted intermediary.
https://www.cbinsights.com/research/what-is-blockchain-technology/

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Blockchain tech’s high level value
Transparency
All blockchain participants are able
to view data added to the chain,
while the chain improves data
integrity by being the single source
of truth
Disintermediation
By enabling transparency and trust,
the blockchain can fulfil the roles
that intermediaries traditionally
provide
Trust
Blockchain’s connected data blocks,
and distributed validation structure
establish trust between participants
without them having to know one
another
Auditability
Blockchain data is immutable and
everlasting, creating an exhaustive
means of record keeping

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What is GxP?
• “GxP” is a collective term for the Good Practice quality
guidelines and regulations used in many fields,
encompassing such internationally-recognized standards
as GMP, GCP, GLP, GSP, GDP and GRP.
• GxP guidelines are designed to ensure that products are
safe, meet their intended use and, in regulated industries
such as drugs, food, medical devices and cosmetics,
adhere to quality processes during manufacturing, control,
storage and distribution.
• The core aspects of GxP are:
– Traceability: the ability to reconstruct the development history of a
drug or medical device or a piece of software.
– Accountability: the ability to resolve who has contributed what to
the development and when.
https://www.slideshare.net/bknanjwade/gxp-and-cgxp-in-biopharmaceutical-industry
See also: https://aws.amazon.com/compliance/gxp-part-11-annex-11/
And: https://www.pharmaguideline.com/2017/01/concept-of-gxp-in-pharmaceuticals.html

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The Key Components of the GxP Domain
Safety
People
Pro-
cesses
Kit
Inputs &
Outputs,
inc. Data
ValidationQuality

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The DLT “Trust Protocol” Enhancing
Compliance?
Blockchain &
Distributed
Ledger
Technology
(DLT)
Safety
People
Pro-cesses
Kit
Inputs &
Outputs, inc.
Data

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DLT & Digital Identity, certificates:
an established use-case
Safety
People
Pro-cesses
Kit
Inputs &
Outputs, inc.
Data
DLT & GxP Opportunities
Blockchain sweetspot:
tracking transactions
Device maintenance records,
ownership, location, etc.
Starting materials, API’s, animals,
results, documents
→ Supply Chains

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DLT & GxP Devices/Kit
https://www.spirituspartners.com/

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The Connected (GxP) Lab
1. Identify
2. Measure
3. Transfer
4. Store
5. Visualize
6. Process
The Internet of
Laboratory Things
(IoLT)

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A Final Thought ...
• Remember
– Compliance is a “Yes-No” thing. You either ARE
compliant - or you AREN’T.
– Blockchain & DLT cannot make you MORE (or less)
compliant.
– Blockchain tech CAN make the GxP systems you
have in your organisation more trusted.
– DLT CAN make the components of your GxP
systems more open and transparent to regulators
and auditors leading to increased confidence in what
you do and building reputation.

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QUESTIONS?
Thank You

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Poll Question 3
• Where do you think blockchain and
distributed ledger technology could play
the greatest role in the GxP domain in
future?
A. People: Training records, qualification certificates and
digital identity
B. Processes: Managing and recording the transactions
through the GxP process
C. Kit/Devices: Maintenance, ownership, location, etc.
D. Input/Output Materials, and Data: Managing the supply
chains around starting materials, reagents, APIs,
animals, results, documents, etc.

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The Role Of Distributed Ledger
Technology
In The GxP Laboratory Of The Future . . .
IOT Lab
Device . . . and why IOTA is
particularly well designed
to fulfill this role.
N.B. Blockchain is specifically a type of Distributed Ledger Technology (DLT) but not all DLTs are based on the
Blockchain data structure. IOTA, for example, is a DLT that uses a data structure known as Directed Acyclic
Graph or DAG for short. Nevertheless, the term “Blockchain” is also often used as a generic term for all DLTs.

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What if all devices in the laboratory were internet
connected and could share their data . . .
Required Data Characteristics:
• Integrity
• Trust and Security
• Immutability
• Ubiquitous and Accessible
• Light Weight
• Cost Effective
Types of Data:
• Experiment Results
• Device Specification
• Device Calibration
• Device Servicing
• Identity of Users
• Usage Data – Date/Time/Duration
IOT Lab
Device
IOT = Internet of Things. i.e. Any device that is capable of connecting to the internet and sharing data.

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This is all made possible with
Distributed Ledger Technology
Distributed Ledger Technology is simply software that can:
• Transfer and distribute data quickly - Ubiquitous and Accessible
• Ensure that the data sent equals the data received – Integrity
• Chains the data together so it cannot be altered – Immutability
• Support the concept of a digital currency - Payments
IOTA though has some enhanced features:
• It can encrypt data and authenticate the source (i.e. MAM) - Trust and Security
• It is specifically designed for IOT devices – Light Weight
• It is a free, open source and public technology – Cost Effective
Secure
Ledger
IOTA NodeIOT Lab
Device
IOTA Client
Data shared using the IOTA protocol
A small piece of IOTA
software on the device
submits a transaction
containing data to an IOTA
Node using the IOTA protocol.
A node picks up this
transaction, validates it
and then submits it to
the network for storage.
A ubiquitous technical standard for the Machine-To-Machine

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What is IOTA?
Not For Profit FoundationOpen Source Software
GitHub
Second Generation Distributed
Ledger Technology
Distributed Ledger Technology is only at the beginning of its evolution.
Scalable and energy efficient
Completely free!
A Data Propagation Protocol
• Gossip Protocol
• Publicly Available
• Permissionless
• Nodes Distributed World Wide
• No Transaction Fees
• MAM – Masked Authenticated
Messaging
• Future Developments - Qubic
Rich and Developing Functionality
Well Funded and Resourced

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So what?
Laboratory as a Service (LaaS)
Scientific Data Marketplace
Research Lab
Database
IOTA Node
Secure
Ledger
The
Internet
IOTA Node
Secure
Ledger
IOTA Node
Secure
Ledger
Laboratory of the Future
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
Laboratory of the Future
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
Laboratory of the Future
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
IOT Lab
Device
Research Lab
Database
Trusted data can now be easily secured,
shared and traded. In fact the built in payment
capabilities of DLTs mean that IOT devices can
even do this directly and autonomously - the
Machine to Machine economy.
IOTA already has an established marketplace
for sensor data.
LaaS as a concept already exists but
combining it with DLT technology brings
significant benefits:
• Trusted data from trusted sources
• The ability to draw consensus from
multiple laboratories / results and pay
for only those that are deemed valid
• Data securely accessed from
anywhere
• “Smart Contracts” and traded capacity
These are just two of the many possibilities DLT technology enables.
How could IOTA
add value in the
GxP domain?

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The Role Of Distributed Ledger
Technology In The GxP Laboratory Of
The Future . . .
IOT GxP
Lab Device
Audit and Regulatory Control
• Using blockchain tech and IOTA, you can now
prove that scientific test results were recorded
at a particular time and place; came from a
particular device; and produced a specifically
stated set of results.
• No one could have tampered with these
results.
• No one could have created them without
actually using the IOT device.
• If used in a GLP/GMP/GCP Lab, IOTA would
provide an additional wrapper of trust around
the data and process.

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Further reading and resources
https://data.iota.org
IOTA Data MarketplaceIOTA Website
https://blog.iota.org
IOTA Blogs
https://www.iota.or
g
IOTA Documentation
https://docs.iota.org
Also - https://qubic.iota.org and https://ecosystem.iota.org

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Questions & contact details
Email: adrian.marks@redkiteprojects.com
LinkedIn: linkedin.com/in/adrianmarks

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Poll Question 4
• Where is your organisation currently in its
journey to blockchain adoption – not just in
the GxP domain, but organisation-wide?
A. Not yet started / have no plans to adopt
B. Plan to begin blockchain proof-of-concept
within next 12 months
C. Considering/working on proof-of-concept
D. Completed proof-of-concept
E. Already implemented blockchain

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Audience Q&A
Please use the Question function in GoToMeeting

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Jake Dreier, Blockchain Project Manager,
Pistoia Alliance
jake.dreier@pistoiaalliance.org
Join us for the next Pistoia Alliance Webinar
Pre-Blockchain Workshop
Community of Interest Meeting:
Moderator: Jake Dreier – Pistoia Alliance
Panelists: Wolfgang Prinz - Fraunhofer Institute
Wolfgang Gräther - Fraunhofer Institute
February 20th, 11am EST/ 4pm GMT

30. info@pistoiaalliance.org @pistoiaalliance www.pistoiaalliance.org