Barbara Unger has shared about the new regulatory expectations regarding GMP Regulatory Intelligence. Indeed, we have heard that FDA inspectors have started asking people about what processes they have in place to monitor new regulations, guidelines, and developments. In part, this is why we offer the GMP Regulatory Intelligence newsletter.
Now, we go deep into a serious issue that has received a lot of attention and press – data integrity. I’d venture to guess that billions of market capital has been lost because of this one issue. The crazy part is this – it’s not even close to being a new issue. As you’ll see, the data integrity story began at least 15 years ago. Continue reading