By Sanji Bhal, Director, Marketing & Communications, ACD/Labs
Data integrity has become an industry buzzword, but do people really understand what it means? According to the FDA, “data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.” For organizations such as the FDA, data integrity is critical to ensuring that manufacturers and pharmaceutical companies are developing drugs that are safe for human use. It’s the organization’s responsibility, in fact, to fully understand the quality and safety of products released for use and consumption to ensure they’ve properly met industry standards before distribution. If they do not meet guidelines, consequences—even post-commercialization—are inevitable. At worst these are represented by product recalls, such as the recent recall of the common heart drug, Valsartan.
While data integrity is critical for meeting regulatory requirements, a recent survey we conducted with Chemistry & Engineering News (CE&N) showed that scientists think about data integrity differently. After gaining the perspectives of 731 individuals working across industry capacities, including academia, nonprofit organizations and government agencies, we found that 86 percent of respondents felt data integrity meant having accurate and consistent data, while 69 percent relate the concept to being able to trace back data through their data management systems.
As pharma/biotech organizations are increasingly required to comply with software requirements across GxP environments to ensure product safety, data integrity initiatives largely seem to be undertaken in these industries. Furthermore, initiatives are focused more on development over discovery where the product is closer to human consumption and data is used to demonstrate good scientific practices. Data integrity is particularly challenging in analytical chemistry where the variety of techniques, data types and formats are so varied. BUT this data is at the heart of critical decisions (both strategic and tactical) and organizations are increasingly seeking ways to improve data management. At a time when the importance and amount of data companies are collecting is more disparate and greater than ever before, being able to search and share data effectively, and the ability to demonstrate data integrity are significant drivers for better analytical data management. While dealing with multiple data sets is a major concern for researchers, we’ve empowered numerous customers with a centralized, easily accessible and searchable live analytical data repository to accelerate decision making and maximize productivity.
Underpinning every regulatory submission is data generated by a scientist in a laboratory, and without data integrity, error and human risk will also underpin every submission. We at ACD/Labs understand the need for a universal approach to recording and sharing data, which is why businesses have relied on our informatics solutions to maintain data integrity for over two decades. As researchers seek assurance of data integrity in the face of evolving regulations, we look forward to continuing to work with the industry to meet the existing and emerging challenges of chemical and pharmaceutical R&D.