Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all. Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important.
According to Kip Wolf, Principal at Tunnell Consulting, “Understanding the importance of data early and often is the best way to reinforce data integrity as a core value in a quality culture.” If we don’t understand the expectation and intent of how we are going to use the data, then we can’t understand what data integrity looks like. Hence, data integrity is relative and the quality of the data is relative as well. The two things are similar but not synonymous and so, it’s relative to how those data are created and used.
Learn more about the dynamic relationship between data integrity and quality culture and the criticality of investing in both early in the business’ maturity from Kip Wolf in the video below>>