Data Integrity, ALCOA+,
Common Issue of Data
Integrity, and How to
minimize the risk of
Integrity.
PREPARED BY: SUBHASISH BISWAS
QA DEPARTMENT
POINTS TO BE COVERED
WHAT IS DATA?
TYPES OF DATA?
DEFINITION DATA INTEGRITY?
WHAT IS ALCOA+?
COMMON ISSUES OF DATA INTEGRITY?
HOW TO MINIMIZE THE RISK OF DATA
INTEGRITY?
Facts, figures and statistics collected
together for reference or analysis. All original
records and true copies of original records,
including source data and metadata and all
subsequent transformations and reports of
these data, that are generated or recorded at
the time of the GXP activity and allow full and
complete reconstruction and evaluation of the
GXP activity (MHRA, Mar- 2018)
TYPES OF DATA?
RAW DATA-
. Raw Data is the original record which captured the first
time either electronically or recorded on paper (manually).
In the case of balance, pH meter instrument data do not
store electronically they provide printed data output that
time printed data consider as raw data. (MHRA, Mar- 2018)
. Complete record in the form of laboratory worksheet,
records, notes, memoranda, microfilms, photographs,
computer printouts, magnetic media, dictated observation,
recorded data from automated instruments also consider
raw data. ( USFDA, Apr- 2016 )
TYPES OF DATA?
SOURCE DATA-
This terminology is used for clinical
investigation purposes. Source data is the
same as raw data (laboratory investigation
purpose). Source data include original records
of clinical observation and investigation.
Source data review by both sponsor and FDA
for safety, quality and integrity (ALCOA+).
(USFDA, Nov- 2012)
TYPES OF DATA?
Metadata-
Data which indicates attributes (Specialty) of other
data and gives reference and meaning of that other
data. Contextual information required to understand
data. Metadata described as data about data. The
audit trail is considered as metadata. Data that
automatically generated by the original data source
also consider as metadata. (MHRA, Mar- 2018)
METADATA
E.g. AUDIT TRAIL
Audit trail is form of metadata having information about
creation, alteration, or deletion of GXP record. This
secure recording of product details during the
manufacturing life cycle. This is the medium includes
Who, What, When, Why chronologically the action
performed. The computerized system responsible for
the generation of raw data always links with an audit
trail to identify the alteration, deletion, or any changes
in data by retaining both altered data and original data.
LIST OF DATA GENERATED IN PHARMA INDUSTRY
BUT NOT BE LIMITED
1. Batch Manufacturing record (BMR)/ Batch Processing
Cleaning Record (BPCR)
2. Batch Packing Record.
3. Training Record.
4. Laboratory Test Report (In Process/ Finished Product).
5. Out of Specification (OOS).
6. Out of Trending (OOT).
7. Deviation.
8. Change Control.
9. Market Complaint.
10. Product Recall.
LIST OF DATA GENERATED IN PHARMA INDUSTRY BUT NOT
BE LIMITED
11. Validation (Analytical/ Process/ Equipment/ Cleaning)
12. Stability Record.
13. Log Books.
14 Returned Good.
15. Job Description of the Employee.
16. Health Checkup.
17. Attendance of Employee
18. Work Orders.
19. Preventive Maintenance.
20. Internal/ External Audit.
21. Audit Compliance.
22. Annual Product Quality Review (APQR)/ Annual Product Review
(APR).
23. Approved Vendor Documents.
WHAT IS DATA INTEGRITY?
. Completeness, Consistency, and accuracy of data
is data integrity. Data must follow the ALCOA+
principle i. e Attributable, Legible, Contemporaneous,
Original, Accurate, Available, Complete, and
Consistent. (USFDA)
. Data are complete, consistent, accurate, legible,
reliable, promt and data maintained throughout the
life cycle. The ALCOA+ principle i. e Attributable,
Legible, Contemporaneous, Original, Accurate,
Available, Complete, and Consistent. (MHRA)
WHAT IS ALCOA+?
. ALCOA acronym was introduced by Stan W. Woollen.
ALCOA represents the terms
. Attributable. This “ + “
represents.
. Legible. - Available
. Contemporaneous. - Enduring.
. Original. - Complete.
. Accurate. - Consistent.
1. ATTRIBUTABLE-
. Clearly indicates who recorded the data / performed
the activity with sign data (manually / electronically).
Record who wrote it and when. FDA requirement is
data should be trace or link with its source like study,
analytical run, test system, etc.
2. LEGIBLE-
. Data should be readable after it is recorded. Data
recorded permanently in long lasting (durable) a
medium like a pen, non-removable ink,. Legibility is
applicable for both printed and handwritten
document.
3. CONTEMPORANEOUS (ONLINE RECORD)-
. Record the Data at the time it was generated i. e
contemporaneously. It is well known online recording
of data. If more promptly (no delay) data recorded,
better the quality. The date of data entry should be
required.
4. ORIGINAL-
. Prevent Data in its unaltered state like raw data.
This is the first data generated electronically or
manually.
5. ACCURATE-
. Data reflect its accurate value / trueness, free from
error. Accuracy indicates quality.
6. AVAILABLE-
. Data should be available for review at any time
until the defined storage of the documents. Available
at the time of Audit and whenever required for review.
7. ENDURING-
. Making sure record exist for the entire period and
readable condition.
THE COMMON ISSUE OF DATA INTEGRITY
Destruction No computer
without system
recording control
Data
Manipulation
Backdated
Documentati
on
COMMON
Lack of
DATA
Audit Knowledge
INTEGRIT
Trail Y ISSUE
turn off
Improper
Data
Share backup
username/ system
password
Cyber Incomplete
Security Data
HOW TO MINIMIZE THE RISK OF DATA
INTEGRITY
FACTOR MINIMIZE THE RISK OF DATA INTEGRITY
Data Limited
Comprehensi Internal Audit Backup computer
ve evaluation access
Follow good Validate
documentati System
on practice DATA
INTEGRIT Manageme
Audit Y nt
Trail Awareness
Quality Training /
Manageme Personnel
nt system Qualificatio
Annual n
product Follow
quality Consultant ALCOA
review Guidance
WHY NECESSARY TO MINIMIZE DATA INTEGRITY
/ FDA BASIC REQUIREMENTS:
Reconstruct the manufacturing process-
.Regulator and industry to be able to reconstruct the
manufacturing process to record.
To Avoid Falsification-
. There is no false, omission, hiding and substitution of
data. Regulatory bodies take serious action on such an issue.
TO AVOID REGULATORY ACTION-
. Regulatory bodies take serious action if
they are not satisfied with your data handling
procedure, product mix-up, cross
contamination, cleaning the procedure,
manufacturing procedure, etc. they consider
its serious cGMP violation.
