© CERULEAN ASSOCIATES LLC

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 man’s “data quality” is another man’s “data governance.”  Without delving into the minutiae of each of these perspectives, I thought I’d offer up five of the resources I frequently call […]

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 integrity terms such as “data lifecycle” and “metadata” and “primary record” used by…  Continue reading at ComplianceZen.com →

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 to using actual samples to perform system suitability testing? and Why is FDA concerned with…  Continue reading at ComplianceZen.com →

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 cost-effective Part 11 compliance. And yet, in nearly every…  Continue reading at ComplianceZen.com →

3 Steps to Determine if Your Software is a Medical Device

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 should take as they develop and commercialize smartphone apps and stand-alone software…  Continue reading at ComplianceZen.com →

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 FDA-483 observations.  Every so often …  Continue reading at ComplianceZen.com →

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 apps. You can see the results and a discussion of the poll online at … Continue reading at ComplianceZen.com →

For FDA, Majority of Mobile Medical Apps are Class II Devices

A June interview with FDA’s Bakul Patel, author of FDA’s draft guidance on mobile medical apps, revealed that the majority of mobile health apps FDA has reviewed to date are classified as Class II Medical Devices.  Of the 27,000 medical apps available today, FDA has reviewed less than … Continue reading at ComplianceZen.com →

Poll – Should FDA Regulate Medical Apps

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 and payors petitioned the Obama administration not to rush … Continue reading at ComplianceZen.com →

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 requirement of nearly all FDA regulations  … Continue reading at ComplianceZen.com →