By Judy Carmody on March 16, 2020

What are the two inspectional focus areas of regulatory agencies? Vendor oversight and data integrity. And agencies expect companies to take a risk-based approach, making them both quite daunting tasks. 

Celia Brown
By Celia Brown
on February 24, 2020

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.