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International Journal of
CODEN: IJRSFP (USA)
Recent Scientific
International Journal of Recent Scientific Research Research
Vol. 11, Issue, 06 (A), pp. 38762-38767, June, 2020
ISSN: 0976-3031 DOI: 10.24327/IJRSR
Review Article
DATA INTEGRITY: AN OVERVIEW
Nikita R. Nikam1*, Priyanka R. Patil2, Mr. Rohan R.Vakhariya3 , Dr. S. K. Mohite4 and Dr. C. S.
Magdum5
1,2
Department of Pharmaceutics, Rajarambapu College of Pharmacy, Kasegaon, Tal. Walwa, Dist. Sangli,
Maharashtra, India. 415404
3
Department of Quality Assurance, Rajarambapu College of Pharmacy, Kasegaon, Tal. Walwa, Dist. Sangli,
Maharashtra, India. 415404
4 ,5
Department of Pharmaceutical Chemistry, Rajarambapu College of Pharmacy, Kasegaon, Tal. Walwa, Dist.
Sangli, Maharashtra, India. 415404
DOI: [Link]

ARTICLE INFO ABSTRACT

Article History: Data integrity is essential to regulatory enforcement and the fundamental justification for the US-published 21
th
CFR Part 11. Food and Drug Administration (FDA) Regulators wanted to make sure that industry collects
Received 4 March, 2020 accurate data during the drug production lifecycle and through marketing consider the number of warning letters
Received in revised form 25th recently issued on data integrity by inspectors around the world. FDA uses the acronym ALCOA to describe
April, 2020 their electronic data standards. ALCOA stands for Original, Attributable, Legible, Contemporary and Correct.
Accepted 23rd May, 2020 This article addresses the concepts, relevance, benefits, drawbacks, regulatory guidelines and data integrity
Published online 28th June, 2020 forms. It also provides details about the risk of data privacy and different approaches can mitigate risk. The
article is going to be very much useful for industry to maintain all data accurate and safe.
Key Words:
Data integrity, ALCOA, U.S. Food and
Drug Administration, Database.

Copyright © Nikita R. Nikam et al, 2020, this is an open-access article distributed under the terms of the Creative Commons
Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original work is
properly cited.

INTRODUCTION prerequisite for data integrity.4 Data integrity is against data

corruption.5
Data can be presented by manually recording an observation,
results or other data and information on paper or by using Principle of data integrity
electronic records using equipment and equipment connected to Systems will be set up and enforced to ensure that all data
a computerized system. A combination of manual and collected, processed and recorded are in compliance with
electronic systems can also be used.1 guideline principles. Data should be provided: 1
The same as DI copies other data sets (such as photos, videos, A = assignable to the person who generates the data
400 DVDs, images and chromatography plates), with all the L = legible and persistent
additional controls necessary for formats such as photography C = contemporary
or scanning 402. There should be a rationale for documenting O = original record (or true copy certified)
the choice of such a method.1 A = accurate
Data integrity is a guarantee of the accuracy and consistency of ALCOA
data throughout its life 2 and is an important aspect of the
design, implementation and use of any system that stores, Attributable
processes, or retrieves data. The term has a broad scope and can The identity of the eligible record holder must be documented.
have different meanings under the same umbrella of a This is usually done by personal signature for paper records
computer, depending on the specific context. It is used as a and dating records with their signatures. Since the file you sign
proxy term for data quality 3, while data validation is a may be a legal document, the meaning of your signature must
be clearly understood. The signature must be independent of a

*Corresponding author: Nikita R. Nikam

Department of Pharmaceutics, Rajarambapu College of Pharmacy, Kasegaon, Tal. Walwa, Dist. Sangli, Maharashtra, India. 415404
Nikita R. Nikam et al., Data Integrity: an Overview

particular person and the tendency to sign the name or initials Sharing of data
of another is fraudulent and must be taken very seriously.6, 7
The database is a part of the enterprise as a whole and can be
Legible accessed by all registered users.
Recordings that cannot be read or understood have no value Improved data integrity
and may not exist. All records must be created to be consistent
with the grammatical assemblies which must be perfectly The integrity of the database ensures the validity and
consistent. It is good to avoid buzzwords, groups and abusers, consistency of the data stored. Integrity is often expressed in
as these are likely to change over time and are often not terms of restrictions, which is the consistency rule prohibiting
understood in a particular locality. It is always a good idea to the violation of a database.
look at anyone else's case as it can highlight most of the Improved maintenance
ambiguities.6, 7
The database system provides data freedom. Changes to the
Contemporaneous data structure in the database will affect the application
All records must be created at the time an activity occurs. For program, which will facilitate maintenance of the database
example, delaying writing to the end will inevitably affect the application.
accuracy of this recording, as the details may not be forgotten Increased concurrency
or remembered.6, 7
The database can effectively manage interactive access to data.
Original This guarantees no user interference so that no information is
All records must be original; the information must be recorded lost or loss of integrity.8
directly on the document. This avoids the possibility of Disadvantages
detecting errors when transcribing information into
[Link] information is printed by the instrument, the print Complexity
is the original recording and must be signed, dated and attached Database management is very complex system software. All
to the recording.6, 7 parties must be aware of its effectiveness and take full
Accurate advantage of it. Therefore, training is essential for
administrators, designers and users.
The record should reflect what actually happened. Any
modification must be carried out without masking or destroying Size
the original information, the use of blanks or modifications of Database management systems consume large amounts of main
liquids is prohibited. Any modification made to the file must be memory as well as large amounts of disk space to operate
signed by the person making the modification and dated to efficiently.
indicate when it occurred and a written explanation must also
be provided. Be aware that records may be required after you Performance
leave the company and may not be contacted for clarification.6,7 The database method is used to provide many applications
Importance of Data Integrity rather than specific applications, some applications may not run
as quickly as before.
The importance of accurate and reliable data while ensuring the
safety and quality of drugs. As the regulator has emphasized Higher impact of a failure
the integrity of the data for many years, the FDA and other Centralizing the database approach increases the vulnerability
global regulators emphasize. of the system. When you respond to all users and the
Advantages availability of the application database, a component failure can
hamper operations and seriously affect customer service.
Control of data redundancy
Cost of conversion
The database system tries to eliminate the extremes by
integrating files. Although redundancy is not completely When switching from a file system to a database system, the
eliminated by the database system, it does control the amount enterprise must incur additional costs for the acquisition of
of redundancy in the database. equipment and training costs.8

Data consistency World Regulatory Guidance on Data Integrity

The Database approach reduces the risk of inconsistency by USFDA-21-CFR

removing or managing redundancy. It ensures consistent 21-CFR (Code of Federal Regulation) is a coding of the
maintaining of all copies of the data. common and permanent rules published in the Federal Register
More information from the same amount of data by the federal government's executive department and agency.
The title of CFR 21 is reserved for Food and Drug
Thanks to the integration of the data used in the database Administration regulations. Each CFR title / volume is updated
system, it is possible to obtain additional information for the once per calendar year on April 1 of each year.11, 12
same data.

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MHRA Essential drugs and health products, WHO is launching data

integrity guidelines to protect patients around the world. It
The guidance on the topic of data integrity expectations for the
involves a number of artists and activities, a fundamental step
pharmaceutical industry is complementary to existing EU
added to the persistence and accuracy of the data submitted by
GMPs for active substances and dosage forms. In the
manufacturers to the National Regulatory Authority. These data
pharmaceutical quality system, data integrity is central to
must be complete, complete and accurate and truthful in order
ensuring that medicines are of the required quality.11, 13
to determine the quality of the studies that support drug
Difference between data security and data integrity: 9, 10
applications in the market. In addition, many standards must be
Table 1 Difference between data security and data followed, namely: good manufacturing practices (GMP), good
integrity clinical practices (GCP) and good laboratory practices (GLP).11,
16
Data Security Data Integrity
Data integrity defines data EMA
Data security defines the prevention of
quality, which ensures that the
data corruption through the use of
controlled access mechanisms.
data is complete and is a The European Medicines Agency (EMA) has announced new
complete design. Good Product Practices (GMP) guidelines to ensure the
Data security deals with the protection of Data integrity deals with the
data. validity of data.
integrity of data produced during testing, production,
Data security is making sure only the packaging, distribution and medication maintenance. Good
Data integrity is making sure
people who should have access to the control of data records is precise and consistent with the data
the data is correct and not
data are the only ones who can access the generated and will help make good decisions by
corrupt.
data. pharmaceutical manufacturers and regulatory authorities.11, 17
Data security refers to making sure that Data integrity refers to the
data is accessed by its intended users, structure of the data and how it Types of data integrity
thus ensuring the privacy and protection matches the schema of the
of data. database. There are two types of integrity of the data: physical and
Backing up, designing a logical integrity. Both are a collection of processes and
Authentication/authorization, encryptions
suitable user interface and
and
error detection/correction in methods that implement data integrity in hierarchical and
masking are some of the popular means relational databases.
data are some of the means to
of data security.
preserve integrity.
For example, a balance for any Physical integrity
account must not be less than
For example, if you have an account in
zero. Such constraints are
Physical integration is the preservation of the completeness and
the “[Link]”, then you have to give accuracy of data during archiving and retrieval. Physical
enforced in the system by
your correct username and password to
access your account or e mail. Similarly,
adding appropriate code in integrity is compromised when natural disasters end, power
application programs. But, outages or hackers disrupt database operations. Due to human
when you insert your ATM card into the
when new constraints are
Automated Teller Machine (ATM), the
added, such as balance should
errors, storage erosion and many other issues, it is impossible
machine reads your ID number printed for data controllers, system programmers, seas application
not be less than Rs. 5000,
on the card and then asks you to enter
your pin code (or password). In this way,
application programs need to programmers and internal auditors to obtain accurate data.18, 19
be changed. But, it is not an
you can access your account. Logical integrity
easy task to change programs
whenever required.
The data does not change due to the logical integrity used
differently in the relational database. Logical integrity data
TGA
protects against human error and hackers, but in a different way
The Australian Regulatory Body Therapeutic Goods from physical integrity. There are four types of logical
Administration (TGA) does not require data integrity in the integrity.
form of scarcity. Lack of practice or process that produced
Entity integrity
could result in a significant risk of delivering a product harmful
to the user. In addition, when it appears that the manufacturer Entity integrity depends on creating unique values that identify
misleads, distorts or improperly engages in products or data.11, the primary key or data elements to ensure that the data entry is
14
not listed more than once and that the fields in a table are not
cGMP empty. It is a characteristic of relational systems that stores data
in arrays that can be linked and used in different ways.
Reflecting on the importance of this issue, the FDA has issued
guidelines on data integrity and GMP compliance itself. The Referential integrity
FDA reports trends that increase data integrity violations.
Referential integrity refers to a series of processes that ensure
Archiving practices in accordance with the cGMP prevent the
that data is stored and used consistently. The rules built into the
loss or obfuscation of data. The FDA's authority for cGMP
structure of the foreign key usage database ensure that only
stems from section 1 of the FD&C Act, "If the methods used,
appropriate changes, additions, or deletions are found. Rules
or the facilities or controls used for this, its production,
may include the deletion of duplicate data entries, ensuring the
processing, packaging, or possession or operation or its
accuracy of the data, and the termination of access to
administration are considered falsified". According to practice,
unapproved data.
it is guaranteed that such a drug will require security Is-lakhali
and their identity and strength and meets the characteristics of Domain integrity
quality and purity.11, 15
Domain integrity is a set of processes that ensure the accuracy
WHO of each piece of data in the domain. In this context, a domain is

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a set of acceptable values which can be included in a column. deletions. In case data is compromised, audit trails provide the
These may include constraints and other measures that limit the breadcrumbs which lead to the problem source.
nature, type and extent of the data entered.
Passwords
User-defined integrity
Use passwords to prevent unauthorized access to all storage
User-defined integrity includes rules and restrictions that the devices where data is stored. Do not place the passwords on
user has created to meet their specific needs. Sometimes the your computer or post-it notes.
integrity of the entity, context and domain is not enough to
Ensure Security
protect the data. Specific business principles are also to be
taken into account and used in data integrity initiatives.18, 19 Cyber-security measures like file encryption can also help to
reduce the loss of data integrity. Anti-malware software is also
Data integrity risks
recommended to block malicious attacks and files from
There is an assortment of factors that can affect the integrity of accessing your computer and manipulating your data.20
the data stored in a database. A few examples include:
Data integrity as applied to various industries
Human error: Data integrity is compromised when a person
The U.S. Food and Drug Administration have created draft
enters incorrect information, duplicates or deletes data, does
guidelines for the pharmaceutical manufacturers required to
not follow the correct protocol, or makes mistakes while
adhere to U.S. data integrity. Code of Federal Regulations 21
executing the process for information security purposes.
CFR Parts 210–212.21 Outside the United States, the United
Kingdom (2015), Switzerland (2016) and Australia (2017) have
Transfer errors: A transfer error has occurred when data
provided similar guidelines on data integrity.22
cannot successfully transfer from one location in a database to
another. Transfer errors occur when a piece of data is present in
Various standards for medical device manufacturing address
the destination table but not in a relational database's source
data integrity either directly or indirectly, including ISO 13485,
table.
ISO 14155 and ISO 5840.23
Bugs and viruses: Spyware, malware, and viruses are software
In early 2017, the Financial Industry Regulatory Authority
pieces that could invade a computer and change, erase, or steal
(FINRA), noting data integrity problems with electronic trading
data.
and money movement surveillance systems, announced that
Compromised hardware: Sudden computer or server crashes, priority should be given to 'developing a data integrity program
and problems with how a computer or other system operates, to track the quality of the data submitted’.24 In early 2018,
are examples of significant failures and can suggest that the FINRA said it would expand its data integrity policy to the
hardware is being compromised. Compromised hardware may "information change management policies and procedures" and
incorrectly or incompletely render data, restrict or disable the assessments of Treasury securities.25, 26, 27
access to data, or make information difficult to use.18
Cloud storage companies have long faced significant
Risks to data integrity can easily be minimized challenges in ensuring accuracy or provenance of customer
or eliminated by doing the following data and in monitoring violations.28
Protect Your Documents Impact of data integrity on pharmaceutical industry
By applying constraints to the files you will secure the records. Data integrity in the pharmaceutical industry includes correct
Vendors like Adobe and Microsoft have the ability to limit data generation and recording, protection of data against
behavior that can be taken on documents-from read-only to accidental or deliberate changes, deletion or loss of data by
making only certain changes. Also, you can encrypt your falsification. The degree of impact from faulty data may vary
documents and PDFs by password. based on the discipline, and therefore the nature of the
investigation, ensuring accurate and truthful data collection is
Introduce Access Controls
essential to maintain research integrity. Improperly collected or
incorrect data can affect the ability of the researcher to answer
Without official access and with malicious intent, personal can
questions correctly and repeat or confirm studies, confuse other
cause serious harm to data. Implementing a minimum privilege
researchers and influence decision-making and lead to wasted
model, where access is accessible only to users who need
resources etc. Data integrity is essential in all areas of academic
access to the data, is a very popular form of access control.
and industrial science research; however, it is even more
Implement Backup and Recovery Procedures critical in the healthcare sector.29
Regular backups of data are critical to preserving data integrity When these data are used to support research, development,
and avoiding valuable loss of data. Data which is periodically registration and advertising of pharmaceutical products for
backed up can be restored in its original form in case of a human and animal health use, there is potential to cause harm
breach. to patients. This is due to the fact that the compromised data
will influence the quality of the final product, i.e. medicine,
Leverage Audit Trails
because the quality of the raw materials in process materials
A time-stamped, computer-generated audit trail tracks the and the finished goods is assured by laboratory data. Later,
name, date and time of data entries, modifications and products of low quality can be unsafe for patients.30

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The Quality Assurance (QA) and Quality Control (QC) Debarment and Imprisonment (for Individuals involved in
methods will assure data integrity. These approaches are data integrity issue)
applied at different studies levels. For example, prior to data
A case study understands well how data integrity issues can
collection, the QA activities take place by establishing quality
affect individuals involved in data integrity issues. A former
systems, optimizing protocols, Formal Operating Procedures
Quality Control Department vice president and three
(SOPs), and training personnel involved in data collection,
supervisory chemists at the now-defunct generic drug
which avoid any data integrity issues prior to data collection.
manufacturer in New Jersey, Able Laboratories, pleaded guilty
On the other hand, after data collection, the QC activities,
to a scheme involving systematic falsification and manipulation
monitoring, analysis and corrective action relating to the data
of their drug test results. Because of this all the 500 Able
take place. Depending on appropriate internal protocols and
laboratories employees, Inc. had lost their job.
SOPs the data will be checked for unintentional or deliberate
data problems in a timely manner by the correct subordinates, Reasons of Data Integrity Issues to Occur
line managers or research directors. A clear communication
There is a common misconception that data integrity problems
procedure between the workers and the supervisor or the
arise only from intentional fraud actions. Deliberate fraud act is
research director would reduce the risk of incorrect data
a single factor that may contribute to data integrity issues but
generation.31
there are several other elements that are equally responsible for
Data integrity issues data integrity issues. A Few elements are mentioned below, 35
Warning Letters, Statement of Non-Compliance and Consent  Time / Work Pressure
Decrees  Insufficient education and understanding
The regulatory authorities have issued several warning letters,  Fear for Mistakes
notification of non-compliance and consent decrees to  Performance pressure
pharmaceutical manufacturing facilities after identifying data  Am told by Leader / Manager to do the activity which
integrity issues. If the regulatory authorities take these types of is against cGMP procedures
action, it will affect the company's ability to get approval of  Reputation Company Culture or Accepted behavior
new drug product for sale, loss of trust by regulatory  Money
authorities. Additionally, a condition may occur in which the  And others.
company needs to minimize the production or keep the goods
on site. This will lead to a lack of pharmaceutical products and CONCLUSION
a loss of consumer trust.32 The integrity of data ensures that electronic data is kept intact.
Import Alert, Product Recalls and Seizure of Products Reports are just as good as the data on which they are based.
The integrity of data can also apply to information outside of
Drug product which has issues with data integrity is called the computer world. Whether digital or written, maintaining
adulterated drug products. US FDA will restrict them from data integrity forms the basis for successful business decision
being allowed on the US market for these adulterated drug taking. As data becomes a commodity it needs to be at the
products. Import alerts inform FDA field staff and the public forefront of the mind ensuring its consistency with minimal
that the agency has ample evidence to require Products that effort. After all, the more data you have at your disposal, the
appear to be in violation of FDA laws and regulations to be more that your business can grow. The quality of data produced
detained without Physical Examination. These violations may by any controlled lab is a prime factor in determining the lab's
concern the product, distributor, shipper and/or other reputation. Recall that inspections and audits can only review;
details.33When an FDA-regulated product is either defective or finding one instance of falsification poses the question of how
potentially harmful, the most successful way of protecting the many more cases of non-compliance exist. Therefore ensuring
consumer is to note that withdrawing it from the market or data integrity is of great importance to every organization's
fixing the issue. analytical scientists, managers and quality assurance, because
Loss of Regulatory Trust the implications of getting it wrong are very costly and it will
take a long time to restore regulatory confidence.
When issues surrounding data integrity arise, they are likely to
result in loss of regulatory trust. This will result in further References
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How to cite this article:

Nikita R. Nikam et al., Data Integrity: an Overview. Int J Recent Sci Res. 11(06), pp. 38762-38767.
DOI: [Link]

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