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
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
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
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
As the regulatory landscape for healthcare apps and Software as a Medical Device (SaMD) begins to firm up, there are three key steps that firms
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
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
A June interview with FDA’s Bakul Patel, author of FDA’s draft guidance on mobile medical apps, revealed that the majority of mobile health apps FDA
The ante has been upped in the mobile medical app regulation debate. Recently, a large group of patient and provider associations along with IT companies
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
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
FDA regulates medical devices such as stents and prosthetics. FDA regulations – and compliance – are predicated on an assumption that medical device production is
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