In the pharmaceutical industry, quality data is the oil that keeps our systems running smoothly. In an increasingly digital world, the complexity of our data has grown exponentially, and, consequently, maintaining its integrity is an ever-growing concern. In fact, poor data quality costs companies $15 million annually on average. Countless people depend on pharma products to maintain their health and even their lives, therefore keeping data integrity intact is crucial to ensuring that products in the pharmaceutical industry are safe and effective.
Maintaining Data Integrity
Pharmaceutical products must be rigorously tested both prior to and following regulatory approval, and data integrity has become a key part of regulatory guidelines. The standards for data integrity vary depending on where the products are produced. For example, products marketed in the U.S. follow the FDA Data Integrity and Compliance With Drug CGMP, which is designed to ensure the quality of pharma products and assure involved parties that the end results have not been tampered with.
Data integrity requires protocols and training for the people tasked with creating and taking care of the data, while also establishing functional and technical features that need to be operational in computerized systems (such as quality control analytical systems, production floor systems, and enterprise IT systems).
One of the challenges of maintaining data integrity is keeping systems up to date. Engineers often face the issue of implementing data integrity requirements in old systems that work just fine but don’t support new regulations, such as recording an audit trail. This creates a need to replace older systems at costs that not every company can afford to incur.
In seeking a more economical path forward, companies are looking for technologies that can prolong the lifespan of these older systems. This is where blockchain technologies can be useful. A blockchain can provide the framework for ensuring data integrity as well as the ability to communicate information to external sources, such as customers and business partners, in a secure and reliable mechanism.
The Value of Blockchain
Based on our experience in testing and validation, blockchain technologies have proven to be mature and reliable. We participated in a use case that implemented a blockchain solution to enforce data integrity requirements on legacy laboratory analytical systems. During the project, the solution not only extended the lifespan of these systems but added value to the business by securing the data all the way from the lab to the end user, who needed to access the results of the lab work.
With a blockchain, we were able to wrap the software, configuration, and data in a blockchain envelope and track the flow of data to make sure it remained complete and unadulterated on its way to the end customer. The process certified that the end result was sound without having to replace the company’s older analytical equipment, saving the company the significant expense of acquiring and integrating new systems.
Additional Use Cases for Blockchain in Pharma
Based on the importance of data integrity in the pharmaceutical industry and blockchain technology’s ability to organize and record that data, there is a treasure trove of opportunities for blockchain in the industry. A blockchain could be used to ensure data privacy in medical records; to collect, store, and analyze data from clinical trials; or to serialize medical products. Serialization, in particular, may greatly benefit from blockchain use, as it would effectively track any drug on a pharmacy shelf all the way down to the raw materials that created it.
Given the conservative nature of the pharmaceutical industry, new solutions are adopted at a snail’s pace. Nevertheless, there are more and more tech professionals working with blockchain technology as well as companies integrating blockchain solutions into their security frameworks. If companies hope to modernize their systems, it will be up to quality management experts to educate the industry on blockchain’s untapped potential.