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How Data Integrity in Pharma Is Key to Compliance?

Building confidence between regulatory organizations and the industry as a whole is facilitated by data integrity. Learn more about data integrity in pharma.

Understanding the Importance of Data Integrity in Pharma

Researching and developing a new pharmaceutical product can be an arduous journey, stretching up to 18 years and costing an astounding one to three billion dollars on average. In an industry where time and financial resources are precious commodities, finding a faster, more cost-effective approach to producing innovative therapeutics without compromising patient safety has become a burning necessity. That’s why understanding the paramount importance of data integrity in the pharmaceutical field is crucial. 

Data integrity serves as the bedrock for ensuring the accuracy, reliability, and completeness of data generated throughout corporate operations and drug production. It is the key player that enables business owners to make informed decisions, elevate the quality of their output, and drive overall success.

The secret to expediting and streamlining the development of drugs lies in high-quality data. A vital component of this endeavor involves maintaining regulatory compliance, as any non-compliance can result in costly setbacks when bringing a drug to market.

In this all-encompassing guide, we will unveil the world of data integrity, equipping pharmaceutical companies with the knowledge needed to navigate this critical facet of their operations. We will delve into the definition of data integrity, shed light on common issues faced by pharma companies, and introduce the invaluable support offered by Xybion, a leading provider of industry solutions.

What is Data Integrity?

Data integrity determines the quality of collected information in the pharma manufacturing industry. The Food and Drug Administration (FDA) and other regulatory agencies consider the data falsified if it does not meet data integrity standards. Data accuracy, completeness, and consistency are all aspects of data integrity. Data security and regulatory compliance, such as GDPR compliance, are frequently called data integrity. It is governed by a set of procedures, guidelines, and standards at the design stage. 

No matter how long it is kept or how frequently it is accessed, the information saved in a database will stay accurate, complete, and trustworthy if the integrity of the data is secure. The pharma industry relies on safe, effective, and high-quality drugs.

The concept of data integrity relies on ALCOA+, which stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Here’s what each of these terms means:

  • Attributable:  This principle requires life sciences manufacturers to recognize and document the entity in charge of obtaining or using a specific data point. Manufacturers should also specify the day and time that data was collected. These distinguishing characteristics provide the data additional context, giving producers or compliance inspectors a more accurate picture of a specific data set.
  • Legible: Businesses rely more largely on paper-based records in less technologically advanced manufacturing operations. The data is, unfortunately, more difficult to understand in such forms since they are more prone to human error. Modern procedures employ digital data extraction and recording techniques, which lower inaccuracy and improve the legibility of the data.
  • Contemporaneous:  Manufacturers must note the exact time of data collection when gathering data. The records should also include the moment when subsequent document updates were made.
  • Original:  In their master record, manufacturers should always use the original data. The initial main data must be used for subsequent processing rather than copies or secondary sources.
  • Accurate: Manufacturers must include accurate, unedited data according to good documentation practices. Without this, data analysis yields inaccurate information affecting business decisions.
  • Complete: Manufacturers of life sciences should retain all generated data. A complete audit trail should include the data modifications and the time any such edits were performed, even when the original data points aren’t in use.
  • Consistent: Data records also need to be consistent, which is related to completeness. In other words, data must be consistent throughout your system when retrieved from different locations. To achieve a consistent view, following any modifications consecutively should also be possible.
  • Enduring: Long after the data collection has finished, records and information need to be kept. In the biological sciences, this crucial information may be resorted to years or decades from now. As a result, businesses typically utilize local and cloud-based backups to save data for an extended time.
  • Available: While it is advantageous to keep data for a long time, it is even more crucial to be able to access that data when required. Therefore, good documentation practices should also include making data accessible whenever authorized parties need it.

Poor data integrity measures can lead to poor product quality or safety concerns. These issues risk compromising patient health. And that’s not all, lackluster data integrity can also lead to sensitive patient health data breaches.

Regulatory Requirements for Data Integrity in Pharma

The FDA data integrity standards are part of its cGMP adherence guidelines. Pharma manufacturers must enforce measures like data evaluation, computer system evaluation and access restrictions, and audit trails into their operations.

The European EMA started enforcing data integrity requirements in 2016. Guidelines include that pharma manufacturers must assess and manage risks to data integrity. In addition, pharma companies must also monitor the data integrity of third parties they contract with.

The UK’s MHRA and the World Health Organization have also recently published guidance on how to ensure data integrity.

Common Data Integrity Issues in Pharma

The field of pharmaceuticals is not immune to data integrity issues, and there are numerous factors that can contribute to their occurrence. These issues can arise from cultural challenges, individual behaviors, inefficient processes, or technological errors.

One prevalent cause of data integrity problems is human error and training gaps, which often result in improper data recording. When data is not recorded accurately, it can compromise several aspects of data integrity, such as attribution, legibility, originality, endurance, and consistency.

Insufficient data storage and management systems also pose a significant challenge to data integrity. Inadequate storage or management practices can lead to data loss, which directly impacts the accuracy, completeness, and availability of data.

It is important to note that the U.S. Food and Drug Administration (FDA) considers any information that does not adhere to ALCOA principles as falsified. While data falsification can sometimes occur unintentionally, there are instances where companies may knowingly engage in such practices. Take, for example, the case of one of the biggest healthcare companies, where the company failed to report falsified data upon discovering it, even if the falsification itself may not have been intentional. Unfortunately, the failure to report data integrity issues is a recurring problem in the realm of pharma manufacturing.

By understanding and addressing these common data integrity challenges, pharmaceutical companies can strive to maintain the highest standards of accuracy, compliance, and transparency throughout their operations.

Remember, data integrity in pharma is crucial for ensuring regulatory compliance, optimizing drug development processes, and ultimately delivering safe and effective therapeutics to patients in a timely and cost-effective manner.

Best Practices for Ensuring Data Integrity

Data integrity issues in the pharmaceutical industry often stem from cultural or organizational factors. It is not uncommon for employees, including leadership, to undervalue the importance of data integrity. However, establishing a company culture that prioritizes data integrity is vital to avoid negative consequences.

To cultivate a culture of data integrity, regular audits and inspections play a crucial role. These assessments enable organizations to identify any potential risks to their information and take proactive measures to address them before they escalate into significant issues.

Fortunately, implementing a robust compliance management solution can greatly support these endeavors. Compliance Builder, for instance, offers valuable features that ensure data integrity and compliance with 21 Part 11 regulations through real-time monitoring capabilities.

By integrating a comprehensive compliance management solution like Compliance Builder, pharmaceutical companies can foster a culture that values data integrity, mitigates risks, and promotes regulatory compliance. This not only safeguards the integrity of critical information but also strengthens the overall effectiveness and efficiency of their operations.

Data Integrity in Pharma: Ensuring High-Quality Data for Compliance

In today’s pharmaceutical landscape, data integrity is no longer an option – it is a fundamental requirement. Failing to maintain robust data integrity practices can have severe consequences, including potential trouble with regulatory agencies such as the FDA. To safeguard your organization and stay ahead in the highly regulated pharmaceutical industry, prioritizing data integrity is paramount. That’s where Compliance Builder comes in.

Are you searching for a comprehensive solution to streamline your data integrity measures? Look no further than Compliance Builder. Our cutting-edge software offers complete automation of your data integrity efforts, significantly reducing risk within your company. By implementing Compliance Builder, you can confidently navigate the complex regulatory landscape and avoid compliance pitfalls.

With Compliance Builder, you gain access to real-time compliance monitoring capabilities, ensuring data integrity and compliance with 21 CFR Part 11. By leveraging our software, global life science organizations can seize new business opportunities while minimizing enterprise regulator risks. Our one-stop solution empowers you to monitor critical information and systems, optimizing your business operations and enhancing overall efficiency.

Ready to take control of your data integrity journey? Book a demo today and discover the transformative power of Compliance Builder. Our dedicated team will guide you through the software’s features, showcasing its ability to safeguard data integrity and streamline compliance efforts. Don’t let data integrity be a roadblock to your success – embrace Compliance Builder and unlock your organization’s true potential.


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