Jamie Colgin

/Jamie Colgin

About Jamie Colgin

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So far Jamie Colgin has created 15 blog entries.

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.

By |2018-08-29T16:51:54-05:00August 29th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|