2. Manufacturing Data-Integrity:
• Scopes & Challenges in manufacturing – 14 minutes
• Analysis of failures in manufacturing – 08 minutes
• Examples – manufacturing issues – 03 minutes
• Management focus & employees’ ownership - 03 minutes
• Ways to control Data-issues – 04 minutes
Sharing & Receiving:
• Q&A with Discussion – 02 minutes
TOTAL - 34 minutes
2
3. 3
Audit failure
Losing Talents
Financial Loss
thus business
Loss of
reputation
Quick
Investigation
Streamlining
management
Cultural
Change
Control on
Failures
S
c
o
p
e
s
C
h
a
l
l
e
n
g
e
s
Rules &
Regulations
Flawless
Business
F
E
A
R
&
P
R
E
A
S
S
U
R
E
M
O
T
I
V
A
T
I
O
N
S
4. 4
Inadequate
processes &
Equipments
• Half-cooked processes transferred to production.
• Lack of process engineering techniques resulted in wrong selection
of equipments. Pilot study was not done or done but in haste.
• Gravity of the data management requirements are not known
Fear psychosis
& Pressure
• Fear of loosing the job influences the hiding psychology thus
employees commit fraudulent actions. Fear of loosing self esteem
can also cause the psychology of hiding and taking shortcuts.
• High pressure from management on timeline, yields, cost can
create the environment of “Data Fraud”.
Work culture &
Employees
morale
• Knowingly or unknowingly wrong process steps are described in the
SOP and in practice different process steps are followed.
• Data recording on a piece of paper and at the shift end BMR is filled
in with mistakes. Hiding practice is normal culture……..
• Demotivated employees, sick employees & disturbed employees.
Data Fraud
5. 5
Failure Sample Flow Chart:
Process
started
Smooth
sailing
Delay in
batch cycle
time
In process
Sample
analysis
Failed
Re-Analysis
without
CAPA
Batch is
Out Of
Control & it
is OOS Auditor
Took the
same batch
as sample
Data was
mismatching
. Auditor
checked the
HPLC audit
trail.
Data
integrity
issue as
output
Good Start
with all
inputs okay
and to the
requireme
nts
Normal
behavior of
batch.
Operators
are
attentive.
Supervisor
is sensitive
Comfort Phase / Startup Phase FDA Audit Phase & Finding NCHush up / Hiding / Alteration
Utility or
other
issues
envisaged
Problem
encountered
with
equipment
but solved.
Shift change
over happened
and reporting
was poor
Batch
parameters
could not
be
maintained
Brainstorming to
save the batch.
Different
suggestions &
Actions lead to
Data Integrity
Issues
Improper investigation. Root
Cause assigned to human error.
CAPA took as training.
Warning
Letter
and
import
alert.
Team tried to
convince
auditors
about CAPA
but they
disagreed and
went to Lab
for
investigation
6. 6
Data Fraud
Data missing
Insufficient records
Data mismatch & wrong entries
Process parameters out of range – No CAPA or deviation
Dual analysis of one sample at two instruments
Back dated data entry with different pen
Altered samples to get the batch passing
Adjustment of yields to get into the BMR range
And many more………….
7. 7
Management focus & Employees’ ownership can change the game.
Safe
Data
Systems
Controls
Training
Culture
8. 8
Electronic controls
System checks
Cultural Change & New
Recruitment system
• Software
• Hardware
• Access control system
• Data logger
• Biometric controls
• Linkage of documents
• Internal Audits
• New SOPs and system
involving Data Integrity
controls.
• Categorization of data
generation points and risk
analysis.
• Training & Development
• Skills mapping & Risk
analysis on Data Fraud
behavior.
• Promoting team work
culture.
Regular training, auditing, data source evaluation, data source monitoring,
categorization of equipments on data fraud risk are essentials in controlling shop
floor related Data integrity issues. Beside these organization cultural change is a
must and new recruitments must be done focusing on data integrity subjects.
