We all “know” FDA doesn’t cite Part 11 in 483s, right? Well, maybe.
Clinical service provider or CRO? Observations of FDA enforcement.
EDC or CRO? Perceptions of data control.
When is a CRO not a CRO? A look at 21 CFR Part 312.
“It’s an approved device!” “Our raw data are paper.” Data integrity excuses that get the best of us confused. In the finale of this 2-post series, we cover counters to these common objections plus share a helpful MHRA resource.
“Where is THAT written?” “It’s an approved device.” “It has a CE mark.” “Our raw data are paper.” Data integrity excuses we’ve all heard before. In this 2-post series, we cover counters to these common objections.
We wanted to capture the wealth of experience we have in GCP Expert Jamie Colgin (or at least a bit of it). So we fired some questions and got some surprising answers.
When site personnel complete subjects’ e-diaries, bad things happen. Don’t let them happen to your company! This post explains the top 3 steps to avoid a costly ePRO 483.
Most of us feel comfortable with paper records. We like to think they’re the same as electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view. Let’s explore a simplified, hypothetical example to help you understand the importance of “content” and “meaning” and avoid an unnecessary 483.