When it comes to cybersecurity, the terms ‘data security’ and ‘data integrity’ are often used interchangeably. Although they are similar in some ways, there are clear differences – and understanding these differences is a crucial step toward protecting data, mitigating risk, and remaining compliant.
In this article, we’ll discuss:
- What pharma data integrity is
- How pharma data integrityit relates to data security
- Why pharma data integrity is crucial to compliance
- The risks of poor data integrity
How Do Data Security and Data Integrity Compare?
What Is Data Security?
As the name suggests, data security refers to protecting databases, files, and accounts on a network from unauthorized access. It involves the use of applications, controls, and various techniques to determine the importance, sensitivity, and compliance requirements of different sets of data. Such efforts are then followed up with appropriate protections.
The three core elements of data security used to protect sensitive data from unauthorized access are often referred to as the CIA triad. These are confidentiality, integrity, and availability.
Limiting access to data only to authorized individuals
Assuring that information is accurate and trustworthy
Ensuring that data is available upon need to allow business functions to progress seamlessly
Data integrity is one of the core elements of data security and involves ensuring that the organization’s data provides value. The primary focus of this element is validity, accuracy, and consistency of data. If there’s an error in transmission or during storage, the data may be secure, but it will not be accurate, valid, and consistent throughout the network.
Pharma data integrity employs a set of rules and mechanisms for recording and receiving data accurately over its whole life cycle. These are aimed at preserving the physical and logical integrity of data.
Data Integrity and Compliance in the Pharmaceutical Industry
Data integrity helps prevent duplication, falsification, deletion, and accidental or intentional modification of data – ensuring that products are developed in a manner that meets consistent standards. Considering the risks and potential losses of delivering substandard or dangerous products to market, investing in data integrity is an obvious decision.
FDA Requirements for Data Integrity
Other than advancing business objectives, pharma data integrity is also important for maintaining compliance with Food & Drug Administration (FDA) regulations. According to Scott Gottlieb, M.D., an FDA commissioner, they’ve uncovered many instances of inaccuracies in data and drug quality over the last decade.
In December 2018, the FDA released an updated version of its Data Integrity and Compliance with cGMP Guidance. With these new regulations, their objective is to clarify the role of data integrity in the development of medical devices, human and veterinary drugs, and biological products. Some of the most important areas of concern are:
- Ensuring data is complete by placing necessary controls
- Documenting activities at the time of performance
- Ensuring activities are attributable to specific individuals
- Recording changes to data
- Taking measures to assess data accuracy, completeness, and compliance, based on established standards
- Ensuring that only authorized persons can change records
With such requirements, pharma data integrity involves the development of flexible and risk-based strategies. This requires the involvement of management teams for the strategy to be adopted throughout the organization.
Even still, there have been reports of such violations, and the FDA is taking decisive steps to address this. In the past few years, they have issued numerous warning letters, consent decrees, and import alerts. Bearing this in mind, companies in the pharma industry cannot afford to risk being subject to scrutiny for data integrity noncompliance.