Why Pharma Data Integrity is a Crucial Component of Security

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. 

• Confidentiality
  Limiting access to data only to authorized individuals
• Integrity
  Assuring that information is accurate and trustworthy
• Availability
  Ensuring that data is available upon need to allow business functions to progress seamlessly

Data Integrity

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.

ALCOA System

Pharma companies use both paper and electronic systems to store data. In either case, data integrity must be maintained. It is for this reason that the FDA introduced the ALCOA system. This is a set of principles that cover different aspects of the pharmaceutical industry, such as research, testing, manufacturing, and the supply chain. It covers electronic, paper-based, and hybrid data as well as other forms of data such as photographs, chromatography plates, and images.

ALCOA is an acronym for its five principles:

• Attributable
• Legible
• Contemporaneous
• Original
• Accurate

To address evolving concerns, the FDA updated ALCOA to ALCOA+, which also includes:

• Complete 
• Consistent
• Enduring
• Available

What are the Risks of Poor Data Integrity?

Pharmaceuticals that have yet to implement appropriate strategies to ensure data integrity are facing increased pressure from the FDA. Apart from these regulatory concerns, here are some additional business risks that result from poor pharma data integrity. 

1. Scrutiny From the FDA

Any error in production can make drugs and medical devices dangerous to patients. It is estimated that there have been over 80,000 deaths since 2008 caused by faulty medical devices and millions more adversely affected. 

With this information now available to the public, consumers have become more cautious about the drugs and medical products they use. Since the FDA is the body mandated to ensure that drugs and medical equipment availed to consumers meet standards, consumers take their recommendations seriously.

As such, any scrutiny in relation to pharma data integrity will raise consumers’ level of caution against your brand.

2. Repeating Clinical Trials

The pharmaceutical industry requires significant investments as the costs of R&D are high. In addition, it is highly competitive, and companies are engaged in a race to innovate, develop, and bring products to market first.

Clinical trials are a crucial step in medical product development. The data gathered during this stage is what determines whether the product is ready for the market. Without pharma data integrity, data from clinical trials may be compromised. Should this happen, you will need to repeat the trials, which will delay product release. 

3. Financial Loss

Since the cost of research and development is high, there is a great need to finish projects on time and within budget. In this regard, pharma data integrity is a crucial element in multiple ways. First, if data errors are detected before launching products, you may be forced to repeat clinical trials and other steps. This will attract additional costs that may affect product pricing.

On the other hand, if such errors are detected after products have been released to the market, you will be forced to recall them. The cost of recalls is so significant that it can lead to bankruptcy, as was the case with A.H. Robins.

4. Litigation

If you release a faulty or sub-par product to the market, the best-case scenario is only having to recall it. Should it result in harm to users, you will be subject to legal action.

Data Integrity Compliance

Pharma data integrity compliance is increasingly becoming a key ingredient for success. Some of the steps you can take to achieve and maintain compliance include:

• Creating awareness and training personnel
• Classifying data based on sensitivity levels
• Tracking data flows
• Implementing access controls
• Preparing for inspections

These efforts are often accompanied by a CRM+EHR solution that ensures data is secure, accurate, and accessible.

Pharma CRM

A CRM can significantly boost your efforts for achieving and maintaining pharma data integrity. However, it’s not just about getting a solution but choosing one that’s reliable and adequately meets your needs.

Penrod is a company committed to supporting the growth of pharmaceutical companies. We use the power of Salesforce to implement a tailored Pharma CRM that engages patients, increases revenue, and promotes pharma data integrity.