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Data Integrity

The document discusses data integrity and its importance for pharmaceutical quality systems. It defines data integrity as the completeness, consistency, and accuracy of data. The ALCOA+ principles of data integrity - attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available - help ensure data integrity. Maintaining data integrity in computerized systems requires assessing the system, data input/output, data changes and entry, security roles, data backup, and capturing changes in critical data fields and the audit trail. Ensuring data integrity helps ensure patient safety and trust between regulators and industry.

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184 views26 pages

Data Integrity

The document discusses data integrity and its importance for pharmaceutical quality systems. It defines data integrity as the completeness, consistency, and accuracy of data. The ALCOA+ principles of data integrity - attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available - help ensure data integrity. Maintaining data integrity in computerized systems requires assessing the system, data input/output, data changes and entry, security roles, data backup, and capturing changes in critical data fields and the audit trail. Ensuring data integrity helps ensure patient safety and trust between regulators and industry.

Uploaded by

kumpir2
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Data Integrity

Ibrahim Terzi
16 May 2023
Content
• Background
• Data and Data Integrity
• Why is Data Integrity Important?
• ALCOA+ Principle
• Data Integrity in Computerised Systems
• Questions
Background
In recent years, FDA has increasingly observed cGMP violations involving data integrity

during CGMP inspections. This is troubling because ensuring data integrity is an

important component of the industry’s responsibility to ensure the safety, efficacy, and

quality of drugs, and of FDA’s ability to protect public health. These data integrity-related

cGMP violations have led to numerous regulatory actions, including warning letters,

import alerts, and consent decrees.


Data Integrity
Data integrity is a fundamental requirement for an effective
Pharmaceutical Quality System which ensures that medicines are of the
required quality.

Poor data integrity practices and vulnerabilities undermine the quality


of records and evidence, and may ultimately undermine the quality of
medicinal products.
What Is Data? What is Data Integrity?

• Data, all information derived or • Data integrity refers to the completeness,


obtained from raw data, for example, consistency, and accuracy of data.
a reported analytical result. Complete, consistent, and accurate data
should be attributable, legible,
contemporaneously recorded, original or
a true copy, and accurate (ALCOA).(2)

• (2) https://www.fda.gov/files/drugs/published/Data-Integrity-and-Compliance-With-Current-
Good-Manufacturing-Practice-Guidance-for-Industry.pdf
Why is data integrity important?
• A product's efficacy, quality and safety can be ensured with reliable and
accurate data provided through data integrity.

• Data integrity helps in building trust between regulatory agencies and


the industry.

• It eliminates the need for inspecting each process involved in the


production and supply of drugs and other pharmaceutical products.
Alcoa (+) Principles

ALCOA+. A commonly used acronym for


“attributable, legible, contemporaneous,
original and accurate” puts additional
emphasis on the attributes of being
complete, consistent, enduring and
available throughout the data life cycle
for the defined retention period –
implicit basic ALCOA principles.
Alcoa (+) Principles
Attributable
Data should clearly state who performed the action and when

Who, when, what and why?

For Example, Data should be attributable, thus being traceable to an individual. In paper
records, this could be done through the use of initials, a full handwritten signature or a
controlled personal seal. In electronic records, this could be done through the use of
unique user logons that link the user to actions that create, modify or delete data; or
unique electronic signatures which can be either biometric or non-biometric. An audit trail
that captures user identification (ID), date and time stamps and the electronic signature
must be securely and permanently linked to the signed record.
Alcoa (+) Principles
Legible
Data should be easy to understand, record permanently and preserved in its original form.

Readable and permanent?

For Example, Data and metadata should be readable during the life cycle of the data. Risks
include the fading of microfilm records, the decreasing readability of the coatings of optical
media such as compact disks (CDs) and digital versatile/video disks (DVDs), and the fact that
these media may become brittle. Similarly, historical data stored on magnetic media will also
become unreadable over time as a result of deterioration. Data and records should be stored
in an appropriate manner, under the appropriate conditions.
Alcoa (+) Principles
Contemporaneous
Data should be recorded at the time of work performed.

At the right time?

For example, when a sample is weighed or prepared, the weight of the sample (date, time,
name of the person, balance identification number) should be recorded at that time and not
before or at a later stage. In the case of electronic data, these should be automatically date-
and time-stamped
Alcoa (+) Principles
Original
Data should be preserved in its original form or a certified true copy.

Unaltered state and ‘true copy’?

For example, data include the first or source capture of data or information and all subsequent
data required to fully reconstruct the conduct of the GxP activity (see the definition of raw
data). The electronic data (electronic chromatogram acquired through high-performance liquid
chromatography (HPLC)) may be the original data and, in other cases, the recording of the
temperature on a log sheet in a room - by reading the value on a data logger – may be
considered the original data. Original data should be reviewed according to the criticality and
risk assessment.
Alcoa (+) Principles
Accurate
Data should be free from error and as per protocol.

Is it the right value/action?

The entry of critical data into a computer by an authorized person (e.g. entry of a master
processing formula) requires an additional check on the accuracy of the data entered
manually. This check may be done by independent verification and release for use by a
second authorized person or by validated electronic means.
Alcoa (+) Principles
(+) Complete
Data should be complete including, test repeat or re-analysis performed on the sample.

Is all information available?


Alcoa (+) Principles
(+) Consistent
Consistent in the generation of records and application of date and time stamps in the
expected sequence

Is the sequence correct?


Alcoa (+) Principles
(+) Enduring
The material used to record the data should be in a manner that will last a long duration of
time without losing readability.

is it securely stored for long-term use?


Alcoa (+) Principles
(+) Available
Data need to be available and accessible for audit review and inspection over the lifetime of
the record.

Is the data accessible immediately??


Data Integrity in Computerized Systems
What is a Computerized system

A system that includes software, hardware, application software,


operating system software, supporting documentation, e.g. automated
laboratory systems, control systems, manufacturing, clinical, or
compliance monitoring database systems, etc... (1)

A Practical Approach to Computerized System Validation


(1)

Kashif Hussain (University of Valenciennes et Hainaut de Cambrésis, France)


Data Integrity in Computerized Systems
Assessment of the system

• Describe the intended use of the computerized system/instrument. Include


references to requirement/design specification documents as applicable.

• List and describe sub-systems, data flow diagrams, applicable procedures, and
system interfaces, including third-party software and spreadsheets. Include
reference to documents as applicable.
Data Integrity in Computerized Systems
Assessment Parameters
Data input/output

• Describe How data (electronic/hardcopy) and results are reviewed/approved


and by whom.

• Create applicable SOP(s)

• Describe if electronic copies are used as true copies of paper or electronic


records and the verification procedure to ensure the copies preserve the
content and meaning of the original data, which includes associated
metadata and the static or dynamic nature of the original records.
Data Integrity in Computerized Systems
Assessment Parameters
Data changes/entry

• Describe who can alter specifications, process parameters, or manufacturing or


testing methods, and by what means (electronic or manual).

Note: Permission to change settings or data should be limited to authorized


personnel only.
Data Integrity in Computerized Systems
Assessment Parameters
Security roles
• Describe the initial data and associated metadata set-up of the instrument/system (e.g.
metadata, master data, attributes, data dictionary, processes and calculations).

• Document the system roles, and identify who can make updates, when updates can be
made and the impact of the changes (e.g. the users with authorized security level in the
system have the permission to set up the data collection and optical bench parameters for
each experiment).

• Identify the roles in use in the computerized system, the controls around the assignment
of the roles and the abilities of each role.
Data Integrity in Computerized Systems
Assessment Parameters

Data backup

• Describe where and how results (electronic/hardcopy) are stored:


• Are the data and associated metadata stored in the workstation automatically?
• Are the data and associated metadata stored on a file server?,If so, how is this
performed and how often?
• Is the data documented or saved at the time of performance?
• Are true copies of dynamic electronic records made and maintained in the
format of the original records or in a compatible format?
Data Integrity in Computerized Systems
Assessment Parameters
Critical data fields and audit trail

• Verify whether the audit trail is enabled to capture changes/deletions/and the


reason for the modification of these events and data in the system
Data Integrity in Computerized Systems
Assessment Parameters
Electronic signatures

• Determine if GxP electronic signatures are utilized in the system.


Describe how electronic signatures are controlled and validated.
Questions
???
END

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