If you are in the pharmaceutical or in the medical devices industry and cannot sleep at night that may very well be due to a lack of confidence in the integrity of the data of your company or that of your contract partners such as laboratories and manufacturers. If you are in the industry and are not concerned it might still not be a good sign. As a matter of fact, many companies apparently ignored the risks that lurked within their and their vendors’ systems and processes. Now they have to take responsibility. Significant reputational damage, import bans, and the immense costs associated with it can be the consequences of data integrity breaches.
Data Integrity – Is It Really All That New?
While lately many cases of data integrity issues and breaches have been reported from companies in India, this is certainly not just a regional problem. It is not an entirely new problem either. What is new though is the increased scrutiny by health authorities such the US Federal Drug Association (FDA) or the EU European Medicines Agency (EMA) towards data integrity breaches. Data integrity is important to health authorities for a very good reason – it impacts the health of consumers and patients. And in drastic cases lives may even be lost.
Thus, data integrity is a prerequisite for the regulated pharmaceutical and medical devices industry. Based on that data decisions are made with regards to product quality and regulatory compliance. Pharmaceuticals and medical device makers, their suppliers of ingredients or services, governmental bodies such as health authorities, insurance companies, health organizations, doctors, nurses, and the patients are dependent on trustworthy data.
The continuing rise of computerized systems, ever new applications, and more recently cloud technology has brought new and manifold challenges to data integrity. Since there are hardly any more records but highly complex digital systems, it has become much easier to change or delete data.
Data integrity is vital for highly complex and integrated systems with multiple interfaces to other systems like in particular enterprise resource planning (ERP) systems. Inaccurate or erroneous data entries can, for example, jeopardize the benefits of cross-functional process flows sought in environments like build-to-order manufacturing or product traceability in the supply chain.
To get things right with regards to your data integrity, you need to be able to prove the records you and your suppliers and service providers generate and maintain are legible, attributable, original, documented in real time, accurate, complete, consistent, enduring and, of course, available when there is an inspection by the health authorities.
In order to be prepared it is, thus, indispensable to have the right quality management system in place, to have your computerized systems validated competently and professionally, and to have mock-up audits performed by quality and compliance experts. Applying these measures will not only allow you to take full advantage of the ever evolving smart electronic data technologies whilst guaranteeing your product quality and regulatory compliance. It will also make you sleep better at night, since you know you are in control of the health, reputational and financial risks that data integrity issues pose to your company.
Author: KVALITO Consulting Group