White Paper

Eliminating Data Integrity

Errors Through Digitization
By Kallik and MasterControl
 White Paper

Across multiple sectors and geographies, government and industry regulators today
harness the power of digital technologies to enforce more rigorous standards. Rather
than allow industries to self-regulate or to rely only on sporadic inspections, regulators
such as the U.S. Food and Drug Administration (FDA) now insist on data submissions
from businesses. The information required includes audit trails detailing how data
was collected, stored, and used; evidence of risk assessment; adoption of a quality
management system (QMS); evidence of certification schemes, sustainability, and supply
chain monitoring, among a host of other metrics.

For businesses faced with these arduous demands, ensuring data integrity can be
challenging. Organizations must know what figures underlie their operations in order to
submit accurate, complete, and timely reports. Their data collection and storage systems
must be robust and transparent. Employees must understand the importance of data
integrity and be trained to take the necessary actions to maintain it.

Falling out of compliance with data integrity can impose significant consequences:

• Mistakes are more likely to occur and recur.

• Product launches may be delayed.
• Products on the market may get recalled.
• Facilities may be shut down.
• Businesses may incur fines – or worse – cease operations altogether.

This white paper outlines the urgent need for businesses to adopt strong data integrity
practices and identifies measures for how to achieve and sustain compliance. It
then explores the practical effect of heightened data integrity requirements on four
industry sectors, each of which faces new regulatory pressures — demanding greater
accountability and transparency of the companies in those industries.

What Is Data Integrity?

In its simplest form, data integrity refers to the accuracy, completeness, and consistency of
data. It also relates to data safety, compliance, and security. If data integrity is maintained,
the information in a database will be complete, accurate, and reliable over time, irrespective
of how many times it is accessed. The two types of data integrity include:

• Physical Integrity – Protecting the completeness, accuracy, and security of the data
within the infrastructure where it is stored and retrieved. Threats to physical integrity
include disasters such as floods or fire, power outages, and hacking disruption. Data’s
physical integrity can also be compromised by human error or by poor storage.
• Logical Integrity – The assurance that data remains unchanged despite being used
in different ways over time through relational databases. It ensures that data always
makes sense within its context.

To sum up the concept of data integrity, the FDA developed the acronym ALCOA as a
helpful way to identify and understand the data integrity standards:1

• A - Attributable
• L - Legible
• C - Contemporaneous
• O - Original
• A - Accurate

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Among the main attributes of data integrity are to ensure that data is:

• The original (or a true copy) and kept secure from modification, corruption, or loss.
• Retained throughout the product’s life cycle.
• Complete and contains all the data’s history.
• Accompanied by all metadata, as well as appropriate validation data.
• Stored in a way that prevents deterioration.
• Searchable and retrievable for audits or legal review purposes.
• Traceable to its origin.

Adhering to these attributes can translate into commercial advantages. According to a

report from consultancy firm McKinsey & Company “Data-driven organizations are 23
times more likely to outperform competitors in customer acquisition, nine times more
likely to retain customers, and up to 19 times more profitable.”2

10 Steps to Achieving Data Integrity

1. Data collection – Implement a reliable data collection process that ensures data will
remain accurate, complete, and consistent. It is better to start with a robust collection
system than to correct records in retrospect.
2. Checking process – Adopt a rigorous checking system by asking colleagues to ensure
that human error is not responsible for data integrity nonconformance.
3. Cybersecurity – Implement cybersecurity measures to protect data against hacking
or malware threats.
4. Company culture – Instill a culture of data integrity through training, education and
awareness of threats, and the need to protect data accuracy, completeness, and
quality. Everyone should share the responsibility of maintaining data integrity.
5. Risk – Identify the risks of noncompliance in your sector, whether from potential
FDA action, privacy regulations, product delays, or a facility shutdown. The practical
implications of any loss of data integrity must be clearly evident.
6. Audit trail – Create an audit trail. This minimizes data integrity risk by showing
where data has originated and how it has been used, transferred, and transformed
through its life cycle.
7. Development model – Incorporate data integrity into the software development life
cycle with governance protocols to help achieve regulatory and security compliance.
8. Validation – Regularly validate computer systems to ensure that data is
processed effectively and IT systems and employee actions are properly
integrated and compliant.
9. Technology – Implement error-detection software that automatically identifies
anomalies and helps prevents future errors.
10. Skills development – Keep data integrity skills up to date by taking data science
courses and liaising with regulators and peers to understand the latest developments.

Data Integrity Regulations in Specific Industries

The data integrity guidelines for regulated products continue to evolve. The expectations
of the agencies involved in the oversight of these products are increasing, given the
capabilities allowed through advancing technologies. This section explains the regulations
that apply to four different industry sectors.

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#1 Medical Device Manufacturers

On May 26, 2021, the European Union’s Medical Device Regulation (EUMDR) came
into full effect, giving increased authority to regulators for overseeing medical device
manufacturers. These regulations were devised some years earlier in response to medical
device scandals, including faulty hip replacements in 20103 and a breast implants scandal
in 2012.4

For medical device manufacturers, the data integrity implications of these new regulations
are widespread and profound. In summary:

• All medical devices must undergo an independent assessment of safety and

performance ahead of obtaining market approval in the EU.
• Benefits to patients along with residual risks must be assessed and published along
with overall risk-benefit analysis.
The [FDA] relies • Each device manufacturer’s QMS must align with the new regulations and be consistent
on truthful scientific across its operations.
data to make • New clinical evidence requirements include both pre- and postmarket data, with each
regulatory decisions, manufacturer maintaining a postmarket surveillance (PMS) system, gathering quality,
performance, and safety data throughout a device’s life cycle.
and we take the issue
of data integrity very These new regulations mirror the FDA’s increasing emphasis on data integrity.
seriously.”
Efforts to Resolve Data Integrity Issues
– Ned Sharpless, former acting
FDA commissioner 5
The FDA urges medical device manufacturers to observe its ALCOA formula for
data integrity requirements. Failure to maintain data integrity increases the risk of
noncompliance, leading to a shortage of crucial medical devices. This can also cause
a company to experience financial and reputational damage.

To assist medical device manufacturers, the FDA issued some guidelines on data integrity
relevant to that industry sector:

• Maintain an audit trail – Set up a secure, computer-generated and time-stamped

electronic record that allows manufacturers to reconstruct events relating to
a record’s creation, modification, or deletion.
• Use electronic instead of paper records – Preserve the dynamic nature
of the records, including associated metadata.
• Validate computer-based workflows – This includes batch records and
control records.
• Restrict access – Limit access of current good manufacturing practice (cGMP)
computer systems to only authorized personnel.

Sustaining Compliance
As with the new European regulations, the FDA stresses the need for a digital QMS, which
helps ensure the integrity of data and compliance with all other regulatory requirements,
while remaining audit-ready at all times. As the agency points out, a digital QMS will
preserve the meaning of original records, allow companies to restore any deleted data,
and avoid out-of-synch metadata during any revision process. It will also track changes
automatically, identifying who made any changes and the reason for the change.

Medical device manufacturers who take data integrity seriously and adopt the right
mindset and technologies to pursue risk-based oversight and prevention will benefit from
enhanced compliance and speed to market. The alternative is a higher risk of stoppages,
delays, and regulatory observations.

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#2 Pharmaceutical Companies
When the FDA compiled a report on 163 drug shortages in the United States between
2013 and 2017, it found that 62% of supply disruptions stemmed from manufacturing or
product quality issues. To reverse that trend, the agency recommended that pharmaceutical
companies adopt a digital QMS to help anticipate and mitigate such problems ahead of time.6

Central to a QMS in the pharma industry is an audit trail. This is a valuable tool for
maintaining data integrity, compliance, and product quality. As the FDA notes in its Data
Integrity and Compliance with cGMP guidance, drug manufacturers are expected to
record the date and time of operator entries and actions that create, modify, or delete
electronic records, and to track actions at the record or system level. This means that
whenever anyone accesses the computer system, renames, or deletes a file, the action
must be recorded.7

Regulators Ramp Up Oversight

The focus on data integrity in pharmaceutical manufacturing has intensified in recent
years, and the FDA is being more stringent with noncompliant companies, issuing
warning letters, Form 483s, and noncompliance notices. It is in the interest of the FDA,
pharmaceutical companies, and public health that this shift towards greater transparency
and electronic data systems continues to progress, enabling companies’ data to be
searchable, accurate, and hard to falsify.

Besides the evident risks to a pharmaceutical company’s finances and reputation,

establishing a robust data integrity program can provide a competitive advantage, helping
to bring products to market more quickly, reduce administration costs and effort, and
assist in new product innovation.

Technology Boosts Productivity

On a broader scale, data integrity in the pharma industry enables companies to gain
the benefits of big data, new technological and digital innovations such as the internet
of things (IoT), automated production systems, and cloud storage to transform drug
development, production, and distribution. Maintaining data integrity ensures that a
pharma manufacturing company’s data is complete, trustworthy, consistent, and accurate
throughout the life cycle of the product, so that medicines reach the necessary quality and
safety threshold.

Becoming an Industry Leader

Adopting a data integrity program and establishing a strong maturity level of data
integrity across the company’s operations and supply chain helps ensure the security
and quality of collected data. The immediate benefits are lower core process costs and
lower potential compliance risks. It can also lead to new commercial opportunities,
including new product development, enhanced existing services, better decision-making,
and valuable insight over consumer sentiment and business operations. Pharmaceutical
companies with the most advanced data integrity practices and programs stand to gain a
significant competitive advantage.

#3 Food and Beverage Producers

Since President Obama signed the Food Safety Modernization Act (FSMA) into law in 2011,
the FDA has taken a more proactive role in regulating food safety. Instead of waiting until
Americans became sick from contaminated or unsafe products, the FDA now obligates
both domestic and non-US food producers to provide wide-ranging data on products as
they progress through the supply chain.8

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Food industry experts agree that reliable data underpins good decision-making and good
science, with product quality, safety, and efficacy all dependent upon data generated
through products’ life cycles. The FDA now insists upon far greater data integrity than in
the past. As a result, the agency has cited food companies for numerous data integrity
breaches, from inaccurate and incomplete records to backdating, fabricated data, and lack
of data to support records.

To achieve regulatory compliance, food companies should adopt digital solutions to ensure
data integrity throughout their supply chains. They can maintain digital continuity and
integrity while complying with industry regulations. Putting data on a digital platform
enables companies to unify their data, applications, processes, people, and external partners.
As a result, data is consistently available in an unaltered, useful, and contextual state.

On its website, the FDA stresses the importance of food safety for the benefit of ensuring
public health. Around 48 million Americans suffer from foodborne diseases every year,
while 128,000 are hospitalized and 3,000 die. The agency argues that if all food producers
followed the FSMA guidelines, these figures would be dramatically lower.9

Overseas food producers exporting into the U. S. must comply with:

• The FDA’s Accredited Third-Party Certification Program – These requirements are

intended to help ensure the competence and independence of the accreditation bodies
and third-party certification bodies participating in the program.10
• The Foreign Supplier Verification Program – Requires importers to perform risk-
based foreign supplier verification to verify that food products are safe, not adulterated,
and not misbranded.11
• Preventive Control for Human Food rule – Requires that organizations take steps
to prevent contamination, including from pathogens in the environment, and verify
that hazards are being controlled. Environmental monitoring and product testing are
examples of steps they may take to verify control of microbial hazards.12
• Supplier verification and approval – Requires manufacturers to be accountable
for ensuring that foreign suppliers are producing food in a manner that meets U.S.
safety standards. 13

Whether coming from overseas or sourced in the United States, the FDA’s requirements
for products that undergo laboratory testing suggest that ensuring data integrity is
paramount. Food importers in the U.S. have a responsibility to provide technically sound
and reliable data. If the FDA questions the integrity of a laboratory’s sampling or testing
program, it can then conduct on-site visits and review procedures.

As a result, food companies are encouraged to invest in strengthening their data integrity
standards related to the laboratories they collaborate with, adopting third-party
accreditation, quality programs, technical competence, and validated methods that, in
combination, improve consistency and produce reliable and integrated data.

#4 Beauty and Fashion Companies

On January 7, 2022, a coalition of New York lawmakers proposed a new regulation: the
Fashion Sustainability and Social Accountability Act (known as the “Fashion Act”). If the
Fashion Act is passed, global apparel and footwear companies operating in New York and
having revenues above $100 million will be obligated to:

• Map (list and track) at least half of their supply chains.

• Publish an annual social and environmental sustainability report.
• Disclose their greenhouse gas emissions and impact on water.
• Report on their chemical management and recycling targets.

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They also need to set annual impact reduction targets to reduce any adverse
environmental impacts.14

Companies found to be noncompliant would be fined up to 2% of their annual revenues

over $450 million to fund environmental justice projects, and their name would appear on a
publicly available list. The threat of negative publicity should compel companies to comply
with the Fashion Act’s guidelines.

More and New Regulations

Business and legal experts view the Fashion Act as a harbinger of regulations to come.
“Sustainability laws and regulations are likely to be proposed in many industries,” noted the
National Law Review. “Virtually all industries are subject to potential regulation addressing
climate change. [The Act] addresses a long-standing justice issue by providing a source of
funding for communities that are most heavily impacted by pollution and climate change.”15

The European Union introduced similar legislation in March 2021 in its Sustainable
Corporate Governance initiative, which includes measurement of environmental, human
rights, and social impacts along supply chains.16

The legislation presents a number of challenges for organizations. For example, providing
data from their own operations and those of their suppliers in a consistent, reliable, and
up-to-date format will require a major investment in data integrity management — adding
potential costs on one hand and enhancing their sustainability credentials on the other. In
the past, many fashion companies have chosen to manufacture goods outside the U.S. in
low-wage regions. They will now have to balance these savings with the additional cost of
reporting and managing data in addition to facing potential reputational and financial costs
if found to be noncompliant.

In the cosmetics sector, the UK Competition and Markets Authority brought in its Green
Claims Code in January 2022, obliging companies to provide evidence when they claim
their products to be clean, green, eco-friendly, or biodegradable. There will also be greater
scrutiny of the sustainability of their products and ingredients.17

“Our customers demand, and deserve, more transparency than ever before,” wrote Dr.
Emma Meredith, Director General of the Cosmetic Trade and Professional Association
(CTPA) in February 2022. She noted that post-Brexit trade arrangements will create
challenges for the sector and that cosmetics companies will need to comply with
differing regulations in the UK, Europe, and worldwide. Data integrity will prove vital in
this endeavor.18

How Maintaining Data Integrity Improves Operations

For companies developing regulated products, maintaining data integrity has become
more critical because companies are collecting, using, and sharing more data now than
ever before. That said, data is seen as a core asset to be turned into intelligence to
maximize the effectiveness of operations.

Companies are generating vast amounts of data as a byproduct of their processes,

information management systems, equipment, personnel, products, communications,
and much more. As a result, ensuring the integrity of exponential amounts of data is
more daunting.

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Data Integrity Noncompliance Is Alarmingly High

According to a Deloitte report, data integrity violations account for more than 70% of
warning letters issued globally. Common scenarios that lead to receiving a data integrity-
related warning letter involve at least one of the following:19

• Laboratory operations do not include complete data derived from all tests, and
procedures are not documented at the time of performance.
• Data is first recorded on an unofficial spreadsheet and later transcribed to an official form.
• Deviations are not thoroughly investigated or accurately documented and corrected in
accordance with regulatory guidelines.
• Test result data is concealed, or tests are performed repetitively until desired results
are achieved.

Quality Data Intelligence

As mentioned earlier, the FDA has long been encouraging the adoption of a digital QMS
in striving for quality management maturity (QMM). This is important not only for the
assurance of data integrity, but to stay current with the evolving regulatory guidelines
and processes.

Achieving cGMP compliance alone does not indicate whether a manufacturer is investing
in improvements to pursue sustainable compliance, which involves having consistent
control over manufacturing performance and quality. A white paper published by the
FDA’s Center for Drug Evaluation and Research (CDER) emphasizes the value and
importance of QMM.

“There is now mounting evidence to support the hypothesis that sites with more mature
quality management practices simply perform better than other sites.”20

Why Data Is a Key Component of QMM

Increased technology adoption and tightening regulatory requirements are increasing the
amount of data that must be gathered and analyzed for quality insights and compliance.

The FDA implemented the Quality Metrics Reporting program to gather data on key
metrics to:21

• Obtain quantitative and objective information about manufacturing quality and reliability.
• Integrate the metrics and resulting analysis into its quality surveillance program.
• Assist in identifying products at risk for quality problems (e.g., quality-related shortages
and recalls).

Cross-Functional Collaboration
Based on the FDA’s assertion about the importance of sustainable compliance,
maximizing operational effectiveness calls for deploying platform technology —
particularly the integration of quality and manufacturing efforts. With more data
and more uses for data, companies have an opportunity to set up a more data-driven,
intelligent organization. Systems and data, traditionally residing in one domain or
another, can now be more transparent. This allows companies to increase efficiency
in all functional areas.

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By digitizing and automating all production processes, your organization can gather and
share data in real time and gain insights needed to:

• Optimize production.
• Reduce deviations and corrective action/preventive action (CAPA).
• Improve right-first-time (RFT) metrics.
• Accelerate product releases.

More Comprehensive Visibility

The life sciences industry is experiencing a technology transformation — particularly
involving the magnitude of data. In pharma manufacturing, clinical teams rely on data
generated during discovery and R&D to help drive a clinical study’s objectives. For
example, pharmacology and toxicology study data is critical to establishing clinical
The use of AI studies’ dosage, safety, and efficacy parameters. Visibility into non-clinical data, risks,
technology is on the results, and timelines streamlines planning and protocol design early in the clinical phase
rise. Reports show: to ensure efficiency and data integrity throughout clinical activities.

• 62% of health care
organizations are thinking
of investing in AI in the
near future.
• 72% percent of companies
believe AI will be crucial
to how they do business in
the future.22
Connecting Data Across the Entire Product Life Cycle
Innovations currently moving through regulatory pathways are made possible through
technologies enabling connectivity, interoperability, and the use of more data. Data is
more abundant and more focus-area specific, which provides more value when used with
advanced technologies, including:
• Artificial intelligence (AI) – An AI algorithm that has a programmed ability to continue
learning and adapting based on the data it receives, making it useful for processes that
involve analyzing enormous amounts of data.
• Machine learning (ML) – A branch of AI that is a technique for designing and training
software algorithms to learn and act on data.

The FDA’s modernization and transformation efforts illustrate how digitization of data
management is the direction companies in the life sciences industry are heading. This
means businesses developing regulated products will find it in their best interest to do
what they can on their end to help expedite regulatory approvals.

A Data-Centered Paradigm Optimizes Quality and Manufacturing

Digitizing the collection and flow of data helps you better understand how your shop floor
is working in order to make data-driven product- and process-related decisions. With
greater access to data from the factory floor, staff can respond faster and more effectively
to situations such as nonconformances, deviations, and CAPAs. Giving stakeholders
immediate access to this data will increase efficiency, reduce unplanned downtime, and
enable end-to-end traceability throughout production and beyond.

End-to-End Labeling and Artwork Management Enhances Data

Integrity Compliance
In May 2022, the FDA published a guidance that focused on label designs that promote
safe dispensing and use to help minimize medication errors. According to the guidance,
sponsors should assess and minimize the risk of medication errors resulting from the
design of product container labels and carton labelling before submitting proposed labels
and labelling for FDA review and approval.23

For example, color coding involves human factors testing and sending the data to the FDA
for evaluation. This emphasizes the importance of maintaining data integrity in all label
design and artwork management tasks.

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With the emergence of cloud-based data systems, true end-to-end labeling artwork
management is now a possibility. This enables the migration of a company’s data, i.e.,
artwork, logos, templates, and approved texts back to the company and away from third-
party suppliers. This, coupled with artwork generating software, allows companies to
generate all their labeling, packaging, and instructions in-house.

Companies also have the potential to organize the processes into a workflow specifically
designed to ensure that compliance is achieved at every step of each process, that
mistakes are eliminated, and that every step of the process is logged and easily proven
to be compliant. The capabilities and accompanying benefits of end-to-end labeling and
artwork management software to ensure labelling compliance include:

• Automated processes – Automating the labeling process can reduce or even eliminate
errors and ensure that stakeholders have completed their task before the next
stakeholder becomes involved. Everyone understands the process, where the label
design is, what the next steps are, and when the task is complete. Each step of the
process is logged and recorded.
• Text, phrase, logo, and template library – This library contains only approved
materials in their correct sizes. It guides users on how to fit and use each item. The
phrase library contains approved text in every language needed.
• Built-in compliance at every stage – No label can be passed onto the next stage
of its production without it being checked and approved by the relevant regulatory
stakeholder. Each change and its subsequent approval are documented.
• Faster time to market – Keeping the processes in-house and automated reduces the
number of errors and noncompliant labels. This dramatically reduces the costs and time
needed to return a product to market.
• Global compliance and label artwork distribution – End-to-end labeling and artwork
management allows a business to centralize its labeling and artwork generation, while
still being able to ensure regional compliance. It also allows for the digital distribution of
its finished artwork around the globe.
• Scale – Changes to large product ranges can be made accurately, quickly, and easily.
Simply change one label and let the automated system make the changes to the rest of
the range.

Automating label design and artwork management helps ensure accurate control and
recording of the production processes. In turn, regulatory compliance becomes less of a
burden, less time-consuming, and less costly.

Conclusion
Maintaining data integrity is no longer a “nice-to-have” or “if feasible” factor on an IT
check list. It has become central to business operations and commercial survival. As
public sentiment around product safety, cybersecurity, supply chain ethics, environmental
responsibility, and standards of governance continues to evolve, businesses will have
to demonstrate compliance with a growing number of regulations. This compliance will
be challenging for some to achieve, but the advantages of data reliability, operational
efficiency, pace of innovation, speed to market, public confidence, and enhanced
reputation will more than compensate for the effort and expense involved.

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About Kallik
The seamless labeling and artwork management system. We enable our customers
to have total control, ownership, access and rapid change management of their labeling
and artwork assets. Kallik is the only fully integrated, cloud-based end-to-end labeling
and artwork management platform that works across global business operations and
enables customers to fully leverage technology to transform their business. Kallik is
simple to use, simple to implement, and requires limited staff training. Our system offers
high performance and high rewards. It is flexible and capable of coping with the growth
and expansion of your business, no matter how successful you are. It also gives you the
potential to use your labeling at a strategic and tactical level in the market. And our
system will deliver significant savings in internal and external costs. Visit www.kallik.com.

About MasterControl
MasterControl Inc. is a leading provider of cloud-based quality and compliance
software for life sciences and other regulated industries. Our mission is the same as
that of our customers – to bring life-changing products to more people sooner. The
MasterControl Platform helps organizations digitize, automate and connect quality
and compliance processes across the regulated product development life cycle. Over
1,000 companies worldwide rely on MasterControl solutions to achieve new levels of
operational excellence across product development, clinical trials, regulatory affairs,
quality management, supply chain, manufacturing and postmarket surveillance. For more
information, visit www.mastercontrol.com.

© 2022 MasterControl Inc. All rights reserved.

WPXXXXGBENA4-06/22

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References
1. “Data Integrity and Compliance With CGMP: Guidance for Industry,” U.S. Food and
Drug Administration, April 2016.
2. “Five Facts: How Customer Analytics Boosts Corporate Performance,”
Alec Bokman, Lars Fiedler, et al, McKinsey & Company.
3. “Johnson & Johnson Recalls Hip Implants,” Natasha Singer, New York Times,
Aug. 26, 2010.
4. “Breast Implant Scandal: What Went Wrong?” Bryony Jones, CNN, Jan. 27, 2012.
5. “FDA Threatens Criminal Action Against Novartis Over Faulty Data Used
in Application for $2.1 Million Gene Therapy,” Berkeley Lovelace Jr., CNBC,
Aug. 6, 2019.
6. “Drug Shortages: Root Causes and Potential Solutions,” U.S. Food and Drug
Administration (FDA), 2019.
7. Supra, note 1.
8. “Food Safety Modernization Act (FSMA), U.S. Food and Drug Administration
(FDA),” Dec. 02, 2021.
9. Supra, note 8.
10. “FSMA Final Rule on Accredited Third-Party Certification,” U.S. Food and Drug
Administration, April 22, 2020.
11. “FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers
of Food for Humans and Animals,” U.S. Food and Drug Administration (FDA)
April 27, 2022.
12. “FSMA Final Rule for Preventive Controls for Human Food,” U.S. Food and Drug
Administration (FDA), July 7, 2020.
13. “What Foreign Supplier Verification Programs Mean for Consumers,” U.S. Food
and Drug Administration (FDA), Aug. 20, 2018.
14. “New York Fashion Sustainability Act: Now In Committee,” Rachel Tarko Hudson,
Alyssa M. Sones, et al, The National Law Review, Apr. 29, 2022.
15. “Is Sustainability En Vogue or the Newest Staple?” The National Law Review,
Feb. 11, 2022.
16. “Sustainable Corporate Governance,” European Commission (EU).
17. “Green Claims Code: Making Environmental Claims,” Gov.UK, Sep. 20, 2021.
18. “Five Reasons for the UK Cosmetics and Personal Care Industry to be Cheerful
in 2022,” Dr. Emma Meredith, Cosmetic, Toiletry & Perfumery Association (CTPA),
Feb. 8, 2022.
19. “Under the Spotlight: Data Integrity in Life Sciences,” Deloitte.
20. “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality
Pharmaceuticals,” Center for Drug Evaluation and Research (CDER).
21. “Quality Metrics for Drug Manufacturing,” U.S. Food and Drug Administration (FDA),
Apr. 5, 2022.
22. “AI In the Pharma Industry: Current Uses, Best Cases, Digital Future,” Samantha
McGrail, Pharma News Intelligence, Apr. 30, 2021.
23. “Safety Considerations for Container Labels and Carton Labeling Design to
Minimize Medication Errors,” U.S. Food and Drug Administration (FDA), May 2022.

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