Moorpark, CA – 10 March 2018 – Jamie Colgin, President of Colgin Consulting, Inc. and Principal Consultant, Validant, will be a featured expert panelist for the Food and Drug Law Institute’s (FDLI) live webinar entitled “Data Integrity: FDA Enforcement and Risk-Reduction Considerations.” The webinar takes place on Tuesday 13 March 2018 from 2:00 to 3:30… [Read More…]
Principle of Least Privilege: 5 Steps to Protect Your Company
Let’s explore the Principle of Least Privilege. What is it? What happens when it’s violated? And, we’ll map out 5 actions you can take to protect your company. You may need to pick up some new vocabulary. Why? Because it will help you have intelligent conversations with your clients and get better results for your company. My sad… [Read More…]
3 Tips for EDC Audit Trails
What follows is more or less a transcript of my presentation at the joint annual meeting of the San Diego Regulatory Affairs Network and the Orange County Regulatory Affairs Discussion Group on 19 Nov 2014. The 3 tips? 1) Use good password reset practices; 2) Don’t allow queries to fire until data are saved; and 3)… [Read More…]
Invisible Ink in GLP and GCP Research
What follows is more or less a transcript of my presentation at the annual meeting of the Pacific Region Chapter of the Society of Quality Assurance on 6 Nov 2014. The conclusion? A proposal that the same requirements for data integrity apply to GLP, GCP, and GMP data and that there is no regulatory basis for claiming… [Read More…]
New FDA Q&A on Data Integrity
On 5 August, FDA published a new set of 7 questions and answers. 3 questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us: Maintain the electronic records created by instrument systems used for your GLP and GCP studies – paper printouts are not… [Read More…]
What Are The Records Anyway?
Tax day in the U.S. has come and gone, and lucky e-filers are already enjoying their refunds. Whether you prepare your own taxes or rely on an accountant, you know the importance of understanding which of your financial records are important and why. The same holds true at work. In the life science industry, we use… [Read More…]
Follow The Trail To Find Data Integrity Problems
How Do I Follow The Trail? One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: “Imagine I’m a sample arriving at your loading dock. What happens to me?” We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and… [Read More…]
