121st CCK & 21st CQS Session Reflections 2022 & Dashboard 2023

1. DATA & SYSTEMS
INC.
A Trust Revolution Company
www.dsic.pk
Application of Data & AI in Pharma 4.0
M Atiq ur Rahman
B.E. (Mechanical)
M.S. (Engineering Management)
M.A.S. (Monetary Economics)

2. About the Presenter
Mr. Atiq ur Rahman is a qualified Mechanical Engineer done his specialization in Engineering
Management and Monetary Economics. He has a vast experience of 27 years in various
process industries primarily in pharmaceutical manufacturing and supply chain. As most of
his deployments comprising of facility design, quality audits and compliance he gets the
tremendous exposures of implementing the regulations in the facility and utility design. Latter
on he turned to the Data Engineering, Data Acquisitions, Automatic Data Logging,
Electronic Recording and Electronic Signatures and practices the concepts of Data Science
in pharmaceutical and other process industries. He undertook hundreds of projects
comprising of facility and utility design including the design of HVAC for pharmaceutical
industry as per regulatory guidelines.
Contact:
WhatsApp: +1(786) 910 6145
Email: atiq@dsic.com.pk
URL: www.dsic.com.pk

3. Disclaimer
Contents presenting are obtained from books,
freely available material and case studies already
published. Resemblance of any information with
any organizational practice will be a coincidence,
however the replications are mentioned with
courtesies where needed. The information presents
is solely my inference and without any connection
with my present organization, customers and past
employers.
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

4. The Objective of Presentation
There few major objectives of this presentation;
1. Overview of Industrial Revolution (Industry 1.0 to 5.0)
2. Overview of Pharma 4.0
3. Data Driven Decision Making
4. Realization of Pharma 4.0
5. The new partner of collaboration in Pharma Value Chain
6. Roadmap to Pharma 4.0; A Digital Transformation
7. Digital Maturity and Operating Model of Pharma 4.0
8. CTQs of Regulatory Compliance; CFR-21 part-11
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

5. 1. 1760: The Industry 1.0; The world started migrating from Agriculture to Machines powered by Water and
Steam (Human Burden and Dependability on Nature had been reduced)
2. 1870 - Industrial Revolution 2.0; The world is getting more Mechanized after the invention of Electrical
Power (Human Burden and Uncertainty of Nature has been further reduced)
3. 1970 - Industrial Revolution 3.0; Migration of industry from huge electrical equipment to small electronic
equipment. Industrial Automation started (Communication was the leverage and World was started
shrinking)
4. 2000 - Industrial Revolution 4.0; When Smart Devices started communicating with the emergence of
Super Computers that can process the Big Data in minimum time. Hence Data Driven Decision was
made by the smart devices
5. Now - Industry 5.0 is focused on humans and artificial intelligence working together. It is also focused
on bringing personalization back into the product market and it is Human-Centered
Overview of Industrial Revolution (Industry 1.0 to 5.0)
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

6. Data Driven Decision Mechanism
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
1. All Humans are designed to take the decisions based on their past experience which is nothing
but a Data.
2. The older you get the higher the data (experience) you achieved and more precisely your
decisions’ output will be
3. The same is with the Machine. The more it acquired data the more it will be precise in its output.
The generic Mechanism of Data Processing;
Data Feelings Intelligence Output
Experience Unlimited Human Accurate
Signals Limited Artificial Very Accurate
Humans
Machines

7. Pharma 4.0
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
Process Sensor Signal Converter
Gateway Server Storage
Analyzer
(Python) Human ML
Cyber
Physical
Cyber-Physical
System

8. “Digital is the main reason just over half of the companies on the Fortune 500 have
disappeared since the year 2000.”
Pierre Nanterme, Former CEO of Accenture
Realization of Pharma 4.0
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
1. Pharma Industry has been considered the slowest industry to adopt the
Digital Revolution
2. Many organizations still rely on paper-based systems to track, record,
and monitor processes
3. In 2017 ISPE first coined the term Pharma 4.0 which is the Convergence of
People, Systems, Data within one Singular Network powered by Artificial
Intelligence

9. Strategies to reach Pharma 4.0
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
• Evaluate the Digital Acceptance of your organization
Digital Maturity
• Are you working with Digital Averters, Digital Neutral or Digital Friendly Mgt.
Check out for Current Technology needs
• Deploy the Right Resources to select the Right Team to get it done
Create a Digital Transformation Roadmap

10. Following are the areas to focus for Digital Maturity
Digital Maturity
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
Computerization Connectivity Visibility Transparency Productivity Adaptability
What
are
the
CTQs
of
Production
to
be
computerized
How
does
data
flow
during
production
and
between
teams
and
sites
How
is
data
currently
retrieved,
and
how
much
real
time
visibility
do
you
have
When
it
comes
to
data
integrity,
how
complete,
accurate,
and
transparent
are
your
records
What
are
your
production
targets
and
how
efficiently
you
can
meet
them
How
agile
your
organization
and
adaptable
to
changing
market
demands

11. Try to develop a team that can write
down the URS of the Technological Needs
aiming the long term company vision and
changing regulatory framework along
with market dynamics and demands
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
Audit Current Technology Needs

12. Digital Transformation Roadmap
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
•If not, think about the talent you’ll need to have in place
before you get started.
Do you have the right workforce in place
to implement new technologies
•Consider the initial investment, as well as recurring costs
What’s your project timeline and budget
•You must have the SMART goals to get it done
What are your anticipated goals and
ideal outcomes

13. The GMP Gap…….
Although GMP ensures the Product Quality but
must be translated as a Quantitative Need clearly
segregated from the individual wishes and
Technological Luxuries and must be handled as
the SMART Objectives
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

14. The Ultimate GMP Goal
GMP must be clearly and exclusively
measurable able at a certain scale therefore
Targeted Compliance Levels should be
measured against the Actual Compliance levels
on the scales of SMART objectives patterns
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

15. GMP Interaction
◦ As the GMP is a knowledge bank therefore qualified and up to
date professionals are one of the mandatory requirements to the
journey of compliance
◦ A defects library must be archived to train the GMP custodians
over the processes especially in the domain of all the technical
departments including Quality Assurance
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk

16. CTQs for the Compliance of 21 CFR part 11
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk
System Validation as per FDA
Part 11 Functionality (Audit Trail,
Detection of Alteration)
Mechanism of Transmission of
Validated Records to FDA
Retriveability of Raw Data till Retention
Period
Controls for Raw Data, Metadata and
Data Attributes for Retention Period
Controls to ensure processed data for
the Retention Period
Controls for Raw Data and Metadata
Security for the Retention Period
Controls on System’s Algorithms on
Results Reproducibility from Raw Data
Controls on the Security of Electronic
Signatures for the Retention Period
Controls on Audit Trails for the
Retention Period

17. Thanks
Any Question……..!
Data & Systems Inc. Contact:+92321 879 0452 www.dsic.com.pk