Jamie Colgin

/Jamie Colgin

About Jamie Colgin

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So far Jamie Colgin has created 13 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+00:00August 29th, 2018|Biopharma / Pharma, CGMP, FDA Inspections, Medical Devices|

FINAL Part 3: Invisible Ink in GLP and GCP Research

“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”

Part 2: Invisible Ink in GLP and GCP Research

“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?