FINAL Part 2: How to Stop the Data Integrity Excuses

Continued from Part 1… Objection 2: “It’s an approved device!” Well, let’s hope so! The question is, “Approved for what?” And the answer is nearly always that it’s approved for use in clinical practice. But… Clinical Practice ≠ Clinical Research Clinical research is subject to higher data integrity requirements than clinical practice. Remember – the clinical […]

Part 1: How to Stop the Data Integrity Excuses

During a clinical lab audit, you come across an instrument that doesn’t have access controls or an audit trail. You raise the problem as a finding during the audit, and the auditee objects: “Where is THAT written?” “It’s an approved device.” or “It has a CE mark.” “Our raw data are paper.” In this 2-post series, we’ll cover: Counters to these […]

“It was the Best Advice Because it was the Worst Advice”

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: How did you get started? I got started by answering a Help Wanted ad in the Detroit Free Press. I was working at […]

Why Isn’t Paper the Same as Electronic?

Most of us feel comfortable with paper records. We can see them, feel them, touch them (apologies to Peter Townshend). 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. What are the 2 keys? Content Meaning Let’s explore a simplified, […]

FDA Draft Guidance on Multiple Entity Registration Requirements

Do you own a food company that rents space to conduct any part of your business? Or, alternatively, do you own a facility that you rent to a food company? If you answered yes to either of the above questions, keep reading to find out the answer to one question you might have, “Do I […]

NASDA and FDA Work Together to Implement the Produce Safety Rule

“FDA takes our responsibility for assuring the safety of the food supply seriously, and food safety is one of my highest priorities as Commissioner. While the United States has one of the safest food supplies in the world, recent outbreaks continue to highlight the all-too-real consequences of foodborne illness, and the need to ensure that […]

FINAL Part 3: Invisible Ink in GLP and GCP Research

Continued from Part 1 and Part 2… Let’s say a sponsor is developing a blood pressure medication designed to bring blood pressure in hypertensive patients down to a “normal” range of 130/80. The medical charts for Subject 1 show a blood pressure of 145/80 at Visit 5, after the Subject has been on study for 2 months. […]

Part 2: Invisible Ink in GLP and GCP Research

Continued from Part 1… GLP When I started in the industry back in 1990, I was a statistician and a statistical programmer supporting GLP studies in general toxicology, reproductive toxicology, and pharmacology. We followed well-written SOPs and validated all of our computer programs. Why? Because as 21 CFR Part 58 was interpreted, these activities were required. […]

Part 3: Drug GMP Warning Letters Data Integrity

Continued from Part 1 and Part 2… CONCLUSION: Data integrity and data governance remain an initiative of global health authorities: The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) was the earliest to enter the area in 2015 with their guidance and a published draft revision in 2016. European Medicines Agency (EMA), World Health Organization (WHO), Pharmaceutical […]

Part 1: Invisible Ink in GLP and GCP Research

Invisible Ink in GLP and GCP Research I believe we’ve stepped off the trail to data integrity and that we’ve been lost for a while now. It’s time to stop, take our bearings, and see if we can work toward agreement on where the trail to data integrity is. It’s my hope that this post […]
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