Where is the technology moving towards and the direction in which we are moving towards, the decision made during COVID out of a dire straits situations should also be made while keeping the finale state in mind and not just a makeshift arrangement? Survival should be the target and not just having a COVID Solution. COVID may also force to directly move to a Pharma 5.0 or IR 5.0.

1. Pharma 4.0 – Optimum
Technology Evolution
Look Inside not Outside !!!
Aniruddha Mehta

2. “Student to Einstein:
2 years ago you have given the same question paper as in
today’s examination.
Einstein:
The questions are same but the answers have changed…

3. Look Inside !
▲Pace of Technology Change
▲Commercial Viability
▲Current Technology Stack
▲Organizational Culture
Global QA Head for a Leading Indian Pharma Company
“AI to me is something that will help me make my
decisions”
The Bridge we need to Build !

4. 9 Technology Pillars for IR 4.0
• Autonomous Robots
• Big Data Analytics
• Cloud Computing
• Internet of Things
(IoT)
• Additive
Manufacturing (3D
Printing)
• Interoperability
• Cybersecurity
• Augmented Reality
• Simulation.

5. 5
A 5 Step Approach to Pharma 4.0
1 2 3 4 5
Look inside at where
we are today
Where we want to be Buy in on technology
disruption
Show, don’t tell Define where to stop

6. 6 6
1
PREPARE
What is the current Technology Stack
which we are working on ?
Inclusions
Suppliers
Support Dept
InventoryManufacturing
Marketing
Research Central Validation Lab
FG/SFG
QC
InputMaterials
T&T & Packaging
Warehouse Management
Analyse
Analyze
QA

7. HR
ERP
HRMS
Intranet
Employee
Management
Payroll
Appraisals
Finance
ERP
Accounting
Taxation
Employee
Cost &
Benefits
Payments &
Receivables
Settlements
Analytics
Marketing
CRM
CLM
BI
Vendor
Management
Supplier
Management
Content
Management
ERP
Manufacturing
ERP
Warehouse
Management
Production
Management
Packaging
Track &
Trace
QA/QC
Instrument
Software
BI
LIMS
QMS
DMS
ERP
R&D
Instrument
Software
BI
LIMS
QMS
DMS
ERP
Data
Management
& Analytics

8. DEFINE
Who | Where | When | Why | What
Optimum need
2
8
Document Management System
 All GxP Documents
 Document Repository
 Work Flow for Document Lifecycle Management
 Document Requirement for all Audits
Laboratory Information
Management System
Quality Management
System
(CC, Deviation, CAPA,
Incidents, Audits, OOS,
OOT)
Learning Management
System
Laboratory Instruments
SAP
Warehouse
Management
System
Integrated QMS Systems
Paperless Validation
Management System

9. Digested disruption
3
9
SUPPORT
How much disruption can
I support ?
Document Management System
 All GxP Documents
 Document Repository
 Work Flow for Document Lifecycle Management
 Document Requirement for all Audits
Laboratory Information
Management System
Quality Management
System
(CC, Deviation, CAPA,
Incidents, Audits, OOS,
OOT)
Learning Management
System
Laboratory Instruments
SAP
Specification Limits Value to sit in LIMS from
Document Management System/
Specification Link available in LIMS
AllQMS related document would reside in
DMS and a link available in QMS as a
reference
AllSOPs would reside in DMS and a 2
way flow for training initiation and
trainingcompletion for document
effectiveness
Batch Record Details to be sent to DMS for a
barcoded BMR from DMS/ Form
management system incase of eBMR
OOS number generated inLIMS which will then integrate with QMS for the investigation and
deviation. On requirement for re-analysis or hypothesis it would be carried out in LIMS and
required details captured in QMS. Similar scenario in case of market complaints aslo
Warehouse
Management
System
Will integrate with LIMS for the following
Analysis Result entry, Instrument Integration,
Instrument Calibration Management, Analyst
Qualification
Batch details to be received fromSAP to LIMS
for further analysis to be recordedin LIMS.
On Completion of Analysis LIMS togenerated
a CoA whichwill be the kick-off point form
BMR entry.
Instrument
generated record
tobe stored in
DMS
Integrated QMS Systems
Paperless Validation
Management System
Allvalidation lifecycle to be managed
here, Risk Analysis to be maintained
here and linked to QMS for all
deviations. Integrated with DMS for
executed document storage and
retrieval. SAP only certain processes
would be validated not the whole SAP.
Lab Instruments would have periodic
validationas well as validation for
changes. Where as a hosted software
system will be a complete software
validationapproach withoperational
validationfor new requirements or
upgrades.
DMS or Form ManagementSystem will
integrate will allmanufacturing system or
MES to automatically pull BMR Data for
generating eBMR.
Can be integrated
with LIMS for
Analyst
Qualification on
IOCPs

10. 10
ENGAGE
Every company is or will be a data
company and data is a guaranteed
disruptor
4
Show, don’t tell Ratio of Data to
Errors
Data
Transformation
Error Rates
Number of
Empty Values
Amount of Dark
Data
Data Bounce
Rates
Data Storage
Costs
Data time-to-
value

11. Know the end at the beginning
5
LEAD
Important to
know where to
stop and not let
the technology
pace take over

12. Principles of The Future Organization
Globally
Distributed with
smaller teams Connected
Workforce
Intrapreneurial
Operates like a
small company
Focuses on
“want” instead
to “need”
Adapts to change
faster
Innovation
Anywhere
Runs in the
cloud
Flatter structure
Tells Stories
Democratizes
Learning
Shift from Profit
to Prosperity
Adapts to future
employee and
manager

13. www.linkedin.com/in/aniruddhamehta