Five Helpful Data Integrity Resources

Looking for reliable, “how to” information around data integrity on the web can be a bit of a challenge. One man’s “data integrity” is another

Parsing Data Integrity Definitions

Earlier this year, the UK’s MHRA published GMP Data Integrity Definitions and Guidance for Industry. This sixteen page document lays out definitions of various data

More Data Integrity FAQs

FDA updated its FAQ page on Good Manufacturing Practices with several data integrity and Part 11 related questions and answers, including:  Why does FDA object

Five FDA Part 11 FAQs

As part of my work with FDA data integrity and Part 11 compliance, I typically address dozens of unique client questions around data integrity and

FDA Inspection Handling – 10 FAQs & Tips

FDA inspections are stressful and worrisome.  Failed FDA inspection costs include sales revenue loss, stock price decline, and public embarrassment from FDA warning letters and

Poll: FDA Needs to Regulated Medical Apps

In a recent poll, 68% of physicians, healthcare professionals, medical app developers, and members of the general public voted that the FDA should regulate medical

FDA Training Records – 3 Risky Challenges

Companies train their personnel in all sorts of FDA-related activities, from quality system SOPs to core regulatory requirements to company policies. Training is a common

Should FDA Regulate Medical Apps?

This week, Congress is holding hearings on FDA’s plan to oversee and regulate medical apps for smartphones as medical devices. As I wrote back in

3D Printing and Nanobots – FDA Challenges

FDA regulates medical devices such as stents and prosthetics. FDA regulations – and compliance – are predicated on an assumption that medical device production is