Column – Blockchain Could Solve Pharma’s Costly Data Integrity Problem
In the pharmaceutical industry, quality data is the oil that keeps our systems running. In an increasingly digital world, the complexity of our data has grown exponentially, and consequently maintaining its integrity is an ever-increasing concern. In fact, poor data quality costs businesses $15 million annually on average. Countless people depend on pharmaceutical products to maintain their health and even their lives, so keeping data integrity intact is critical to ensuring that the products of the pharmaceutical industry are safe and effective.
Maintain data integrity
Pharmaceutical products must be thoroughly tested both before and after regulatory approval, and data integrity has become a central part of regulatory guidelines. Data integrity standards vary depending on where the products are manufactured. For example, products marketed in the United States follow the FDA Data Integrity and Compliance With Drug CGMP, which is designed to ensure the quality of pharmaceutical 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 maintaining the data, while also establishing functional and technical capabilities that must be operational in computerized systems (such as quality control analysis systems, production floor systems, and enterprise IT systems). ).
One of the challenges of maintaining data integrity is keeping the systems up to date. Engineers often face the problem of implementing data integrity requirements in legacy systems that work just fine but do not support new regulations, such as recording an audit trail. This creates a need to replace older systems at costs that not all companies can afford to incur.
As they seek a more economical path forward, companies are looking for technologies that can extend the life of these legacy systems. This is where blockchain technologies can be useful. A blockchain can provide the framework to ensure 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 analytical laboratory systems. During the project, the solution not only extended the life of these systems, but added value to the business by securing the data all the way from the laboratory to the end user, who needed to access the results of the laboratory work.
With a blockchain, we could wrap the software, configuration and data in a blockchain envelope and track the flow of data to ensure it remained complete and unadulterated en route to the end customer. The process confirmed that the end result was sound without having to replace the company’s older analysis equipment, which saved the company significant expenses in 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 this data, there is a treasure trove of opportunities for blockchain in the industry. A blockchain can be used to ensure data protection in medical records; to collect, store and analyze data from clinical trials; or to serialize medical products. Serialization, in particular, could greatly benefit from the use of blockchain, as it would effectively trace any drug on a pharmacy shelf all the way back 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 technical 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 about blockchain’s untapped potential.
