Protecting Our Data

Data Integrity Awareness

1
Background
• We gather a large quantity of data related to our research,
manufactured products, testing, and our organisation
• Need to continually improve how we gather, manage, store
and use our data
• Regulations require our data to be accurate, reliable and
traceable throughout its lifecycle
• Need to implement an approach to Data Integrity (DI) that
prevents issues, ensures compliance and builds trust
• We need a blame free culture that supports speaking up
about concerns

2
 Imagine…

How would you feel? Would you continue to trust your bank in the same way
after an incident like this one?
If the same type of breach happened at here, would you feel comfortable if a
member of your family took the drug or used the product?

3
Background
• ‘Simple’ errors like the bank scenario, in our industry,
could have a major impact on the quality of our
products.
• Data is part of the product and is a valuable asset:
─Without data, we cannot produce a product!

─Data provides confidence to the person at the end of

the supply chain and Health Authorities that products
are safe and effective.

4
Objectives
At the end of the training, you should be able to:
1. Explain why Data Integrity (DI) is important
2. State 3 consequences of poor Data Integrity
3. Identify Data Integrity requirements and your personal
accountability
4. Understand your role in embedding data integrity into the
workplace

5
What is Data?
◦ When you hear the word ‘Data’, what comes to mind?

◦ What data do we generate through our day to day activities?

Take a moment and list all the different types of data.

6
What is Data?
Data:
Pieces of information that can exist in
different forms electronically or on paper.
Data can be numbers, text, graphics,
audio, pictures, or graphs and can be
presented as raw data or as final results
and reports. It includes all recorded GMP
data such as batch records, logbooks, lab
results, notebooks, etc.
Raw data may be on paper that is
manually generated and recorded (e.g.
IPC checks during production), OR may be
generated and stored electronically, such
as data produced by lab equipment and
captured by a Laboratory Information
Management System (LIMS).

7
What is Data Integrity?
 What does Data
Integrity mean to you?
Integrity:
A core value which includes
the quality of being honest
and the state of being
complete or whole. It means
data is reliable, complete,
consistent, accurate and
secure throughout the data
lifecycle (from when data is
generated to end of
retention requirement).

8
Data Integrity Issues
• Data integrity issues can happen because of unintentional and deliberate
behaviours and actions
• Unintentional issues are often the result of poorly designed processes
and procedures, mistakes or lack of understanding.
• Deliberate issues are actions to deceive or mislead. These often occur
as a result of trying to hide or cover up a mistake or issues. These
include:
• Falsification of data, e.g. backdating documents, signing for actions
not completed or witnessed
• Omissions or deletion of data
• It is ALWAYS better to explain mistakes or problems openly so they can
be resolved quickly and accurately.
• Whether the data integrity issue is unintentional or deliberate, it impacts
the safety and quality of our products.
• Even good intentions can lead to poor data

9
Examples of Data Integrity Issues
A number of data integrity issues result from poor processes or practices,
or from high-pressure situations as there is more of a tendency to take
short cuts or deviate from the ‘normal process’.
Here are some examples:
• Operator signs the “Witnessed By” field on the manufacturing record
for addition of an ingredient even though they were not present at
that time due to multiple, competing duties. What’s the potential
impact of this?
• An analyst reprints a worksheet to record new, passing data and
discards the previous worksheet that contained failing data. What’s
the potential impact of this?
• An old instrument has a single logon/ password. What’s the
potential impact of this?
Each one of these data integrity issues could impact the quality and
efficacy of our products and safety of the person at the end of the
supply chain.

10
Importance/Consequences of
Data Integrity?
• If the integrity of the data generated has not been maintained,
there is no confidence in the product. This means that we are
failing the person at the end of the supply chain, for example:
• Recalled product on the market leads to mistrust and confusion
for the person at the end of the supply chain
• Stopping manufacturing of product, can lead to product
shortage or no product in the market
• We could also lose the trust of our Regulators who ensure our
products are safe and effective

11
Understanding the
requirements for Data
Integrity

12
Understanding the
Requirements for Data Integrity
• Now that we know what data integrity is and understand some of
the risks related to data integrity, let’s learn about some ways we
can protect data.
• We will review key data quality attributes that support data integrity
for both electronic systems as well as paper records, and understand
our responsibilities in regards to these attributes.
• All recorded GMP Data (electronic or paper based) should follow
Good Documentation Practices.
• Good Documentation Practices are standards governing the creation,
control, distribution, use, retention, and disposal of GxP documents
and records.

13
Regulatory Authority Expectations
 Regulators expect companies to strictly control all GxP data
and can therefore demonstrate high levels of data integrity

 Trends in data integrity issues across the industry has led

Regulators to issue guidance on expectations. These can be
easily remembered by the acronym ALCOA.

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Data Quality Attributes – ALCOA
Attributable
• Each entry must be recorded, initialed and dated
by the person performing the action
• Sign only for work you have performed or an
activity that you have witnessed
• Electronic systems should retain all information
as an audit trail
• Keep electronic passwords secret and secure
• Always Log Out or lock your computers when not
in use!

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Data Quality Attributes – ALCOA
Legible
• Electronic data should be easy to read and access
• Handwriting must be legible/readable in records,
reports, etc.
• Record all data in permanent ink
• Changes made to data must not obscure/delete
the original entry
• Use a single line to cross out and do not use
correction fluid for paper records
• Electronic systems must retain all changes
through audit trails

16
Data Quality Attributes – ALCOA
Contemporaneous (Real time)
• Information must be captured at the time of the
activity by the person who performed/witnessed
it
• Back-dating is never permitted
• Retrospective entry of ‘missing’ information or
data must include an explanation,
signature/initials and date
• Only use approved forms / documents to record
all GMP data

17
Data Quality Attributes – ALCOA
Original
• Original data (also known as ‘Primary Data’ or ‘Raw
Data’) is the first information captured and must never
be obscured or removed
• Always check the raw data when reviewing and
approving reports or records
• Data must never be deleted and must be accessible
throughout its lifetime
• Keep all documents / records (even if it has been
invalidated)
• Take appropriate steps when correcting a
documentation error to maintain a history of incorrect
entries or changes

18
Data Quality Attributes – ALCOA
Accurate
• Data must be free from errors with no missing
information (including all failing and invalidated
results)
• Others must be able to verify the
processed/calculated data
• Data entered consistently in the required format
(e.g. correct decimal places with the correct
units)
• N/A, date and initial any blanks or empty spaces

19
Scenario 1
Situation:
While collecting samples, Ken (initials KST)
mistakenly left the sample site blank. Quickly
after completion of the task, Ken realized his
oversight but because the batch record was now
being used by other employees, he could not
make an annotation.

Ken decided to note the sample site on an

available piece of paper with the intention to add
the missing information once the batch record
became available.

During the end of shift review, Ken’s blank entry

was noted by a team member and the batch
record was returned to him to address the missing
sample site.
Special Sample Request (NA if none taken)
Sample
Process Performed By /
Volume (L) Sample Site Sample ID
Step # Date
X.xx
Step .3 L S1327496 KST /
6.3 15MAY15
Step AAM
1.46L E437-B S1327775 20
7.8 15MAY15
Scenario 1
Which ALCOA attributes are
Attributable missing or at risk?

• Primary Issue: Missing information/Sticky

Legible Note
◦ Risk Attributable, Contemporaneous,
Contemporaneo Original, Accurate
us

• Secondary Issue: Inconsistent sample

Original volume
◦ Risk Accurate
Accurate

21
Scenario 1
For the missing ALCOA attributes, what would be an
appropriate course of action to ensure data integrity is
maintained?

• It is not
Lesson appropriate to record GMP data on a non-GMP source (e.g.
Learnt
scrap paper).
• STOP
STOP andand talk to
rapidly yourtomanager
speak and Quality
your manager about the
and Quality situation.
if unsure about
• We
how tomust retain
handle the original
missing data which
or incomplete data in
. this case is the scrap
paper. If there is no additional evidence available, e.g. electronic
record, the scrap paper should be retained with the batch document.
• Before retrospectively entering data (or asking others to do so),
think through the situation and determine what supporting
documentation is needed.
• Review the current process and see how the situation can be
avoided in the future (e.g. not removing the batch record from the
area before all data is entered).

22
 Scenario 2
Ahmu is an experienced operator but today has been asked to
help with storing bulk product, a task that he is trained on but
does not perform regularly.

Ahmu completed all steps as directed in the batch record and

documented all required information as he completed each step.
However, it wasn’t until he had transferred the bulk material to
the container that he realized a second signature for the weight
was required prior to the transfer.

This weight was taken by an ‘off line’ scale so the weight was not
captured anywhere else.
Performe Verified
Step # Operational Description Data Entry d By/Date By/Date
6.1 Storage
Scale Used: Tank Used:
SC-B563 T-1103 AHU /
Equipm Equipm 03MAY1
• Confirm Scale is available for GMP use
ent ent 5
and has been calibrated within 24hrs.
Calibrati
YES Calibrati
YES
on Valid on Valid
• Confirm from the logbook that Scale
Status Status
has been CLEANED within 24hrs and
is is
record the Date and time of last
CLEANE
YES CLEANE
YES
cleaning
D D AHU /
Time 03MAY1
• Confirm from the logbook that the 5
and Date of
status of the Tank is CLEANED and 01MAy1
Date of 14:00 03MAY15 Cleanin
record the date of cleaning 5
Cleanin g
g
• Perform pre-use visual inspection prior
Visual Visual
to transferring material AHU /
Inspecti Inspecti
on
YES on
YES 03MAY1
(Must be verified prior to transfer) 5
PASSED PASSED
AHU /
Weight Transferred
(_ _._kg)
42.6 kg 03MAY1
5
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Scenario 2
Which ALCOA attributes are
Attributable missing or at risk?

• Primary Issue: Lack of Verification

Legible ◦ Risk Contemporaneous, Accurate

Contemporaneo • Secondary Issue: Inconsistent entries

us

◦ Risk Accurate
Original

Accurate

24
Scenario 2
For the missing ALCOA attributes, what would be an
appropriate course of action to ensure data integrity is
maintained?

• Ahmu needs to involve his supervisor immediately and discuss the

Lesson Learnt
situation with Quality to determine the impact of missing this
verification step.
Review procedures and documents prior to performing an unfamiliar
• There may be a need to raise a deviation as this could be a critical
task to see if/when additional support is required.
step and the procedure was not followed.
• A standard format should be in place for all data entries.
• First line leaders should evaluate the tasks required and prioritize
the teams actions based on capabilities and proficiencies.

25
Scenario 3

Alicia was asked to complete Mixing Step B that a coworker had been working on.

Alicia reviewed the step and noted that the only action required of her was to record the
mixing end time and calculate the elapsed time, ensuring it has mixed for a minimum of 15
minutes.

Alicia stops the mixing after the required 15 minutes and was about to record the stop
time in the batch record when she realized the time on the wall clock and the time within
the system are a couple minutes off. Alicia does not know which clock was used to capture
the initial start time. Additionally, her coworker had also already signed and dated the
performed by box as she started the mixing step.

26
Scenario 3
Which ALCOA attributes are
Attributable missing or at risk?

• Primary Issue: Multiple time sources

Legible ◦ Risk Accurate

Contemporaneo • Secondary Issue: Previous Operator

us
already signed step

Original ◦ Risk Attributable, Contemporaneous

Accurate

27
Scenario 3
For the missing ALCOA attributes, what would be an
appropriate course of action to ensure data integrity is
maintained?

• If possible, check with the co-worker that started the mixing – confirm
what clock was used. If the coworker cannot remember then
immediately
Lesson Learntescalate the situation to the supervisor to determine what
to do.
• Alicia must co-sign the “Performed By” within the batch record for the
Minimise
activity the
she sources of variability
performed. There areand includewhere
situations your multiple
name if employees
you help
perform
work on a task.
the same task/activity, we must have the information to identify
all the employees that performed that task.
• Alicia must notify her supervisor to remove the potential of this issue
happening again. Consider removing the wall clock if there’s no need for
it or clarify which clock should be used in the procedure.
• Need to look at the document design to identify ownership of each
task/data. For tasks that can be broken up between employees, design
documents to accurately capture who started the task and who finished
it.

28
 Scenario 4
Audrey, a lab analyst, is making a correction to a
document (highlighted below) she completed
during her analysis that day. Her lab maintains
all documentation electronically which requires
her to scan and save the document as an
attachment within the Laboratory Information
Management System (LIMS).

When Audrey sits down at the lab terminal she

notes that another analyst is still logged into the
computer and has the program that she needs
opened to make her update.
Equipment Manufacturer Equipment ID Number
Column Dionex ProPac WCX-10 Analytical Column (2.0 x 250 mm) C#16434533-B2
Waters Alliance 2690/2695 with Waters PDA 996/2996 HP#26321
HPLC System
Detector or 2487 Dual wavelength Detector
Equipment Pipette Volume Equipment ID Number Next Calibration Due Date
Adjustable Pipette 0.1-1.0 mL P-S112 P-S115 01FEB2016
Adjustable Pipette 1.0-10.0 ml P-M047 02JUN2016
Acquisition Information File Name
Project P-1453
Sample Set P-1454-978-B2
Result Set ID B2-14563-A
Performed By Audrey Sinclair Date 27Jun15 29
Scenario 4
Which ALCOA attributes are
Attributable missing or at risk?

• Primary: Employee not logged out of

Legible program
◦ Risk Attributable
Contemporaneo
us
• Secondary: Corrected data obscuring initial
entry
Original ◦ Risk Legible, Original

Accurate

30
Scenario 4
For the missing ALCOA attributes, what would be an
appropriate course of action to ensure data integrity is
maintained?

• Audrey should not perform the task under someone else’s login ID. She
must either
Lesson log them out or use another terminal. If the system does
Learnt
not allow a user to log out someone else, contact system admin or
supervisor to log the user out.
Always log out when you move away from work terminals and never
obscure
• IT mayany of to
need thebeoriginal
involveddata.
to provide an appropriate solution (e.g. have
the system automatically log out a user after a set period of idle time).

• The proper way to correct a written data entry error is to put a single
line through the entry, provide an explanation, and initial and date.

• She should consult her supervisor and Quality to find out how to address
the issue with the obscured data. Data must always be legible.

31
Scenario 5
Simon is assisting another employee perform a regular facility check. Per site
SOP, these checks are required to be conducted in a particular order and
documented using a bound facility maintenance log book.

They are running behind schedule and they decide that the checks can be done
faster if they split up the tasks. As a result, several pages are removed from
the log book so that they can both perform checks simultaneously.

At the end of the day, Simon looks to return his completed pages to the
facilities log book, however, the other employee has already left for the day.
Simon decides to secure the documents in his locker and leaves for the day.

32
Scenario 5
Which ALCOA attributes are
Attributable missing or at risk?

• Primary Issue: Removed pages from bound

Legible notebook/Stored in locker
◦ Risk Original
Contemporaneo
us
• Secondary Issue: Maintenance checks not
performed in order
Original ◦ Risk Accurate

Accurate

33
Scenario 5
For the missing ALCOA attributes, what would be an
appropriate course of action to ensure data integrity is
maintained?

• A deviation may need to be raised as tasks were not completed

sequentially
Lesson Learntas per required procedure.
• Notebooks are bound to ensure the integrity of the data being
Continuous
recorded.improvement
Never removeispages
good, from
however
boundensure that changes to ways
notebooks.
of• Putting
workingGMP are controlled
documentsproperly and
in private seek advice
lockers from the
or removing appropriate
them from
groups before
premises implementing
could (e.g.
result in them Quality).
being lost. Without records to confirm
critical steps, products could be considered by Regulators to be
adulterated.
• Speak up and raise the time constraint concerns with the
supervisor so that the task can be appropriately scheduled or
resourced.

34
Next Steps

35
Data Integrity Culture
 There are 6 key enablers to ensuring a good Data Integrity culture is in
place:

1. Blame free environment - openness and transparency

2. Simple processes and procedures that are clearly understood
3. Leaders listen and act on issues/concerns raised
4. Mistakes are seen as a learning opportunity – focus on the
problem not the person
5. Supervisors/First Line Leaders are present in the local area
6. Everyone is focussed on quality – not just supply

 Take a few minutes to reflect and discuss these points. Can you answer
‘yes in place’ to each of them?
 If not, talk to your leaders after this training session about how they
can be improved in your area.

36
Summary
• Following the ALCOA principals is essential whether you are dealing
with paper or electronic data.
• It is important to always follow procedures as it ensures the
integrity of the data.
• If you perform an operation that does not allow the recording of
data in real time, escalate this to your line manager.
• The impact and effort of remediating a data integrity issue
afterwards is always greater than doing it right the first time or
dealing with mistakes openly and honestly when they occur.
• Data integrity is important to demonstrate that products have been
manufactured and tested according to approved processes. If we get
it wrong, we risk losing the trust of the person at the end of the
supply chain and the Regulatory Authorities.
• The person at the end of the supply chain relies on us
to be responsible when handling our data

37
Objectives Review
1. Why is Data Integrity (DI) important?
• Regulations require our data is accurate, reliable and traceable
throughout its lifecycle
• Need an approach to Data Integrity (DI) that prevents issues, ensures
compliance and builds trust
2. What are 3 consequences of poor Data Integrity?
• Loss of trust from person at end of supply chain
• Recall / Stopped Production could lead to interruptions in supply
• Regulatory observations/sanctions
3. What are the Data Integrity requirements?
• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

38
Expectations of Learners
 Think about data integrity in your area of work and identify
any gaps or potential risks. Discuss with your line manager
how to close any gaps.

 Remember the ALCOA acronym and apply the principals in

your daily work.

39
Thank you
• Thank you for taking this training course.
• By keeping the ALCOA principals in the forefront of our
minds when dealing with data, we can prevent data
integrity issues and maintain compliance so that we can
supply safe and effective products to our to person at the
end of the supply chain.
• Keep in mind that there is a person at the end of the
supply chain that relies on us and our data!

40
Questions?

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