The importance of data integrity in the pharmaceutical industry is a topic that has received increasing attention in recent years.
Data integrity is an important aspect of current Good Manufacturing Practice (cGMP) compliance, according to a draft guidance issued by the U.S. Food and Drug Administration (FDA). In addition, the European Medicines Agency (EMA) and the UK’s Medical and Healthcare Products Regulatory Agency (MHRA) also emphasize the importance of data integrity in their publications.
Although these guidelines are not “non-binding recommendations”, data integrity is often an important issue during pharmaceutical audits and inspections.
In this article, we will examine in detail the importance of data integrity and how pharmaceutical companies can ensure compliance with these regulations.
WHAT IS DATA INTEGRITY?
Data integrity refers to the completeness, consistency and accuracy of the data. It is important that the data is Attributable, Legible, Contemporaneously Recorded, Original or a True Copy and Accurate (ALCOA).
All of these attributes ensure transparency and reliability of data within companies and towards third parties, such as regulatory and compliance entities.
In the pharmaceutical industry, compliance with these regulations is crucial to ensure patient safety and drug efficacy.
Data Integrity in Pharmaceutical Industry
IMPORTANCE OF DATA ACCURACY IN THE PHARMA SECTOR
Digitization has brought several advantages to pharmaceutical processes, including the ability to search data faster, make backups, and bring together data from different sources to provide new insights with advanced analytics or artificial intelligence.
However, as the amount of data increases exponentially, the risk of integrity also increases. Human error is more likely when entering data into electronic systems, access breaches can occur if robust permissions methods are not in place, and automation of data collection through IoT / IIoT can increase the amount of erroneous data.
As many documents are emailed, downloaded, uploaded and shared, and data is used multiple times to run simulations or scenarios, it becomes difficult to determine which ones are the originals.
This new paradigm of digitization requires an innovative approach to data integrity in the pharmaceutical industry.
COMPLIANCE WITH DATA INTEGRITY REGULATIONS
Data integrity is crucial for regulatory compliance in the pharmaceutical industry. Regulatory agencies and pharmaceutical companies need accurate and reliable data to ensure the safety, efficacy and quality of a product. Current regulations, such as ALCOA+ and guidelines issued by the EMA, MHRA and FDA, highlight the importance of data integrity and set out the requirements needed to ensure it.
Data integrity is also essential to build a relationship of trust between the pharmaceutical company and the regulatory agencies. Agencies cannot evaluate every detail of processes and production, so they must rely on the integrity of the data provided by companies. In case of non-compliance, the consequences can be serious, such as product recalls, company image problems and even harm to patients.
For example, the ALCOA+ data attributability requirement requires that all data collected be attributed to the person or team that generated it. An example of a data attributability failure was highlighted in FDA warning letter 320-20-10. The letter indicates that the company failed to exercise appropriate controls over computer systems to ensure that only authorized personnel can make changes to master production and control records or other records.
Pharmaceutical companies must implement a data integrity management system to ensure regulatory compliance and avoid potential regulatory issues and reputational damage.
DATA INTEGRITY SOLUTIONS
Data integrity is crucial in the pharmaceutical industry to ensure the safety and quality of the products marketed and their production processes.
In this sense, it is important to have a set of measures in place to prevent data manipulation and to have a complete and traceable history of data throughout the organization.
To this end, it is important to identify and assess vulnerabilities in the performance and security of computer systems, such as configurations, administrative permissions, password controls, auditing capabilities, network requirements, among others. In addition, it is essential to have an adequate backup system, ensure that hardware and software are suitable for their intended use, and conduct proper change management and management oversight.
Data integrity is not just about network security, but involves the entire organization, from back-office processes to production.
Because of its importance, we have decided to dedicate a space to it in this blog.
ALCOA is an essential framework used by regulated industries, particularly the pharmaceutical sector, to ensure data integrity and maintain Good Documentation Practices (GDP). The acronym was coined in the 1990s by Stan W. Woollen of the FDA’s Office of Compliance. The ALCOA principles apply to both paper and electronic data and are crucial to effective data management and governance.
ALCOA represents five key principles.
- Attributable: All data must be attributable to the person or machine generating the data including who performed an action and when. It can be accomplished by recording manually by initialing and dating a paper record or by audit trail in an electronic system.
- Legible: All data must be legible and permanent. Ensuring records are legible and permanent assists with its accessibility throughout the data lifecycle including the storage of paper and electronic data.
- Contemporaneous: means to record the paper or electronic data at the time it is performed. Date and time stamps should flow in order of execution for the data to be credible. Data should never be back dated, or forms completed with expected results prior to execution.
- Original: is the medium in which the data point is initially recorded including protocol, form, notebooks, spreadsheet, database, or software application. Understanding where the original data is generated to ensure content and meaning are preserved.
- Accurate: data should be free from errors, complete, truthful, and reflective of the observation. Editing should only be performed by using the principles of GDPs and editions should be registered.
The European Medicines Agency (EMA) expanded upon the ALCOA framework in 2010 by adding four additional principles to ensure data integrity in the pharmaceutical industry.
These principles include completeness, consistency, enduringness, and availability.
- Completeness means that there should be no missing data related to a process, product, or operational workflow.
- Consistency requires that the data’s sequence of events should be in the expected order and appropriately date or time stamped to demonstrate contemporaneity.
- Enduringness means that the data should be appropriately recorded in a robust and long-lasting system.
- Lastly, availability requires that the data should be readily available for review, audits, or inspections for the required lifetime of the record and indexed and labeled appropriately to facilitate retrieval.
By adhering to these guidelines, companies can prevent errors and data manipulations and ensure that their products meet FDA data requirements.
In today’s world, data is one of the most valuable resources. Therefore, it is essential that companies take measures to ensure its integrity.
Data integrity implies the accuracy, consistency and security of information. To implement it in your organization, it is essential to identify the key players and critical applications that rely on data. Also, consider incorporating technologies that ensure data integrity into your processes, devices and applications.
It is important to establish a long-term plan that will enable critical systems and applications to comply with data integrity guidelines in your organization. Make sure you take steps to protect data integrity in your organization and optimize your decision making!
The pharmaceutical industry is becoming increasingly data-driven, so maintaining data integrity is essential. This blog aims to help industry players understand the basics of data integrity, as well as the guidelines and regulations applicable to it.
In future posts, we will focus on specific use cases and technologies that can accelerate digital transformation in the pharmaceutical sector through trusted data. If you would like to learn more about data integrity for the smart pharma industry, please feel free to contact us!
Armilis is a leading deep tech company that specializes in data integrity, providing solutions to ensure the consistency, authenticity, and accuracy of data throughout its life cycle.
Our software layer is based on cryptography and blockchain, enabling seamless integration with any system, resulting in enhanced trust, efficiency, and security for existing or new digital infrastructures.
We cater to Industry 4.0 and the SMART world, where data is vital to daily operations, focusing on delivering unparalleled data management and governance solutions.