Data Integrity refers to the completeness, consistency and accuracy of the data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or true copy and accurate across. The acronym ALCOA has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is a key to Good Documentation Practice (GDP).

1. Ensuring Data Integrity
through ALCOA
Compiled By:
Abhijeet Waghare
Team Member- Quality Assurance and Compliance
Piramal Enterprises Limited
API Division, Digwal, Telangana-502321
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2.  Data Integrity refers to the completeness, consistency and
accuracy of the data.
 Complete, consistent and accurate data should be attributable,
legible, contemporaneously recorded, original or true copy and
accurate across.
 The acronym ALCOA has been around since the 1990’s, is used
by regulated industries as a framework for ensuring data
integrity, and is a key to Good Documentation Practice (GDP).
 ALCOA relates to data, whether paper or electronic, and is
defined by US FDA guidance as Attributable, Legible,
Contemporaneous, Original and Accurate.
DATA INTEGRITY
(DI)
2 Ensuring Data Integrity through ALCOA

3. Basic DI principles applicable to both Paper and Electronic
systems (ALCOA)
Ensuring Data Integrity through ALCOA3

4. Who observed and recorded the information?
When the data was observed and recorded?
 Attributable, the identity of the person creating a record should be
documented.
 All data generated or collected must be attributable to the person
generating the data.
 This should include who performed an action and when (in simple
words, who observed and recorded the information and when the data
was observed and recorded).
 A correction on a record should be initialed (signed) and dated to show
when and who made the adjustment.
 For paper records, this is manually done by the individual signing and
dating the record with their signature.
 As the record you may be signing may be a legal document you should
clearly understand the implication of your signature.
ATTRIBUTABLE
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5. Note:
 It is important to ensure a signature log is maintained
to identify the signatures, initials and/or aliases of
people completing paper records.
 A signature should be individual to a specific
individual and the practice of signing someone else’s
name or initials is fraud and is taken very seriously.
ATTRIBUTABLE
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Ensuring Data Integrity through ALCOA

6. Can the information be easily understood?
 A record that cannot be read or understood has no value and
might as well not exist.
 All data recorded must be legible (readable) and permanent.
 Ensuring records are readable and permanent assists with its
accessibility throughout the data lifecycle. This includes the
storage of human-readable metadata that may be recorded to
support an electronic record.
 It is always a good practice to have any record reviewed by a
second person as this can often highlight any ambiguities.
 GDP will always promote the use of indelible ink when
completing records.
 When making corrections to a record, ensure a single line is used
to strike out the old record. This ensures the record is still legible.
LEGIBLE
6 Ensuring Data Integrity through ALCOA

7. Was the information recorded with timeliness?
 Contemporaneous means to record the result, measurement or data
at the time the work is performed.
 Date and time stamps should flow in order of execution for the data
to be credible.
 Data should never be back dated. All records must be made at the
time an activity takes place.
 Delaying writing up, for example until the end of the day, will
inevitably affect the accuracy of the record as details can be
forgotten or miss-remembered.
CONTEMPORANEOUS
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Ensuring Data Integrity through ALCOA

8. Is the source information (data) accessible and preserved in its original
forms?
 Original data, sometimes referred to as source data or primary data is the
medium in which the data point is recorded for the first time.
 All records must be original; information must be recorded directly onto
the document.
For example:
 Ensure validation test results are recorded on the approved protocol. This
avoids the potential of introducing errors in transcribing information
between the documents (recording results in a notebook for transcription
later can introduce errors)
 If information from an instrument is printed out by the instruments that
print out is the Original record and should be signed, dated and attached
to the record.
ORIGINAL
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Ensuring Data Integrity through ALCOA

9. Does the recorded information describe the conduct of the
study/activity without errors?
Who made corrections and when corrections were made?
 The record must reflect what actually happened.
 For data and records to be accurate, they should be free from errors,
complete, truthful and reflective of the observation.
 Any changes should be made without obscuring or obliterating the
original information; the use of white out or correction fluid is
prohibited.
 Editing should not be performed without documenting and
annotating the amendments. In simple words, any changes made to
a record should be signed by the person making the change and
dated to show when it was made and a written explanation should
also be provided.
ACCURATE
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Ensuring Data Integrity through ALCOA

10. Ensuring results and records are accurate is achieved through many elements of a
robust Pharmaceutical Quality Management System. This can be comprised of:
a)equipment-related factors such as qualification, calibration,
maintenance and computer validation.
b) policies and procedures to control actions and behaviours, including
data review procedures to verify adherence to procedural
requirements
c) deviation management including root cause analysis,
d) impact assessments and CAPA
e) trained and qualified personnel who understand the importance of
following established procedures and documenting their actions and
decisions.
Together, these elements aim to ensure the accuracy of information.
ACCURATE
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Ensuring Data Integrity through ALCOA

11. Let’s come to the ……SUMMARY
 Attributable: It should be possible to identify the individual who
performed the recorded task. The need to document who
performed the task / function, is in part to demonstrate that the
function was performed by trained and qualified personnel.
 Legible: All records must be legible – the information must be
readable in order for it to be of any use. This applies to all
information that would be required to be considered Complete,
including all Original records or entries.
 Contemporaneous: The evidence of actions, events or decisions
should be recorded as they take place. This documentation
should serve as an accurate attestation of what was done, or
what was decided and why.
Ensuring Data Integrity through ALCOA11

12.  Original: The original record can be described as the first-capture
of information, whether recorded on paper (static) or
electronically (usually dynamic, depending on the complexity of
the system).
 Accurate: Ensuring results and records are accurate is achieved
through many elements of a robust Pharmaceutical Quality
Management System. This can be comprised of:
a) equipment-related factors such as qualification, calibration, maintenance and computer
validation. b) policies and procedures to control actions and behaviours, including data
review procedures to verify adherence to procedural requirements. c) deviation
management including root cause analysis. d) impact assessments and CAPA. e) trained
and qualified personnel who understand the importance of following established
procedures and documenting their actions and decisions.
Together, these elements aim to ensure the accuracy of information.
Ensuring Data Integrity through ALCOA
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Ensuring Data Integrity through ALCOA
Abhijeet Waghare
Email: abhi.waghare173@gmail.com
Twitter: @AbhijeetWaghare
Mob.: 9075671915