Author: Jamie Colgin

Data Integrity

Part 1: How to Stop the Data Integrity Excuses

“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.

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Electronic VS Paper

Why Isn’t Paper the Same as Electronic?

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.

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