Proving and preserving data integrity for pharmaceutical regulatory compliance
How important is your data? For any manufacturer, keeping good data is good for business. But for a pharmaceutical company, operating in one of the most highly regulated industries in the world, data is vital. Bad data can get a drug banned from the market - and the standards for data quality and integrity are going up.
In the last few years, a major shift in the way pharmaceutical companies are regulated has been underway at the US FDA. Bolstered by the passage of the FDA Safety and Innovation Act in 2012, the agency has stepped up inspections at foreign plants and intensified its focus on the data collected by drug manufacturers.
According to a 2016 report by the Health Research Institute, the FDA issued five citations to pharmaceutical companies for data integrity problems between 2010 and 2012. In the next three years, from 2012 to 2015, the agency issued 24 - a nearly fivefold increase.
“Data integrity violations can shut down facilities,” the authors of the report write. “Data integrity issues can lead to import bans, recalls, public warnings, detained products, delayed or denied drug approvals, lawsuits, lost business and costly remediation efforts.”
The good news, for pharmaceutical manufacturers, is that improving data integrity isn't just a way to stay on the right side of the law. Better data means better research, better decision making, smoother plant operations, faster time to approval, and ultimately better drug development.
In another 2016 paper, the Health Research Institute analyzes the risks businesses face under the FDA's new approach, but also the benefits:
“The broader use of standardized metrics by the industry will support benchmarking across sectors, potentially leading to efficiencies and improvements. The use of trusted third-parties to collect, analyze and compare data will allow companies to leverage this information.”
Since 1980, OSIsoft has been a source of robust data management tools for businesses in a diverse array of industries, from research to manufacturing to energy production. One of those businesses, Swiss pharmaceutical manufacturer Sandoz, has relied on OSIsoft's PI System to provide secure and sophisticated data architecture since 1996.
At an OSIsoft Users Conference in 2016, Sandoz's head of data systems, Alexander Haimayer, told attendees that the PI System plays a vital role in helping the company shine under an increasingly bright regulatory spotlight.
“We have really good inspection results,” Haimayer said, “because we have a clear story of how we do data archiving.”
For a drug manufacturer, the importance of robust and accurate data goes far beyond plant inspection results.
“In the regulated production environment, data is the evidence to our patients and health authorities that our products are safe and effective. It tells the story of a product long after it is shipped,” he said.