Corrective and Preventive Action in Pharmaceutical Industry

The use of data is an integral part of every system and sector. One core sector where data is so highly valued is the pharmaceutical industry. Not alone does this industry use data, it also places a premium on data integrity.

In this blog post, we will analyze what data integrity is and its importance. We will also highlight poor data integrity issues and how to improve data integrity. If you work in pharmaceuticals, life science & biotech operations, then this is for you.

What is Data Integrity?

Data integrity is the maintenance of the accuracy and consistency of data. Likewise, it concerns the safety of data without any alteration throughout its life cycle.

In today’s digital world, data collection is essential to gathering vital information from  primary and secondary sources. It gives insights into an existing problem in an industry.

Hence, data collected must be reviewed, cleaned, and analyzed. This will help in drawing meaningful conclusions needed for the next step. To add to this, it will improve data integrity.

Importance of Data Integrity

Pharmaceutical and biotech companies gather and store data at all times. However, the quality of this data must not be compromised. Here, we shall examine why these companies must maintain data integrity.

 1. Safety & Effectiveness

Data integrity gives the certainty that drugs are safe to use. It also proves that drugs will be effective when used. This is because every piece of information about manufacturing is protected.

For drug effectiveness, data integrity plays a huge role. It does this by combining three factors – collection, analysis, and evaluation. It allows for predictive analysis that ensures that new drugs manufactured are effective in the market.

For instance, it is not enough to identify Chloroquine as an anti-malaria. Data integrity will use the three factors mentioned earlier to determine dosage. This will help to avoid toxicity, overdose, ineffectiveness, and drug intolerance. Thus, data integrity is highly essential in pharmaceutical and other regulated industries.

 2. Accuracy

There is preciseness in data integrity. Well-cleaned data guarantees its exactness and relevance. It also makes it easy to trace data when needed. For more clarity, it helps pharmaceuticals to remove unreadable data. It also helps to perform final quality assurance checks.

 3. Effective Production and Distribution

Compliance with data integrity procedures aids drug production and distribution. Data integrity helps pharmaceuticals to produce the right kind of drugs. In the same vein, it helps them to supply those drugs to the right customers.

Let’s say a pharmaceutical company realizes an increase in the COVID-19 rate in a part of the country. This could spur it to produce COVID-19 treatments. Data integrity, for all aspects of production and manufacturing is essentially in consistently producing the highest quality treatments.

 4. Trust Building

When data is compromised in a pharmaceutical company, it is hard for consumers to trust such a company. Also, other companies would avoid all forms of association. In a case where data integrity is maintained, trust is built and retained. 

The pharmaceutical & biotechnology industries must keep secure documentation practices. This will improve the level of trust regulatory agencies have in them.

Poor Data Integrity, Poor Compliance, and FDA Letters

In the United States, the Food and Drug Administration (FDA) is responsible for regulating the activities of food and drug-related companies. The body also ensures that these companies maintain a high level of data integrity.

The FDA sees this as a way of maintaining a premium management system and consumers’ safety. To see that companies adhere to regulatory policies set, the FDA uses several ways.

Poor data integrity and poor compliance with the FDA pose a great risk to the success of pharmaceuticals and biotechnology industries. It also  causes inaccurate documentation.

That said, it further leads to a decrease in quality drug production. Abstaining from set requirements also increases production costs and disrupts the supply chain. It also decreases customer satisfaction.

However, poor compliance gets companies sanctioned. The FDA could serve companies with a warning letter or Form 483 observations. Likewise, it could lead to the seizure of products that do not meet regulatory standards. This way, data integrity is enforced to ascertain voluntary compliance.

How can we Improve Data Integrity?

Not only should pharmaceutical and biotechnology companies maintain data integrity. The industry must should strive to improve it because of the risks. Let’s take a quick look at ways to improve data integrity.

 1. Validation

At the collection stage, care must be taken to ensure that data is not altered. To do this, your company should put the data through thorough validation. This will help to validate system performance and that data is entered, stored, and maintained appropriately. its validity after every error has been removed.

 2. Clean-up & Backup

Regularly, your database should be checked for duplicate data. The integrity of your company’s data can be compromised when there is excess duplicate data. It also brings about data inaccuracy.

Likewise, data backups should be performed on a regular basis. This serves as an extra form of accessing data in a case where there is data loss or system compromise. 

 3. Auditing

Through auditing, your company will realize changes to make to data, where to make them, and when to. This will reveal where there is a loophole or risk, and how to fix them.

In conclusion, data integrity is a fundamental requirement that pharmaceuticals must adhere to. This improves consumers’ safety in the prescription and use of critical treatments.

Since 2017, OpsTrakker’s commercially available, off the shelf solutions have provided customers with expertise regarding data integrity, increased ROI, and reduced time to value. The range of digital solutions, including electronic use-logs, forms, records, and more can be instrumental in any regulated environment.  Thus, if you need well-analyzed and highly efficient data that complies with the FDA standards, Opstrakker Solution Suite and eLogBooks are the go-to solution.