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…]
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…]
Why Do UAT On Service Provider Systems?
Outsourcing services is quite common in clinical development. We outsource everything… Lab analysis of subject samples (central clinical labs) Interpretation of subject medical images (central imaging readers) Data capture at clinical sites (EDC and ePRO) Randomization and management of investigational product (IVRS/IWRS) Trial master files (eTMF) …and the list goes on and on…. [Read More…]
Do I HAVE To Validate This System?
If you’ve been in QA any length of time, you’ve been asked this question. If you weren’t sure yourself, you may have called a systems auditor for help. When you finish reading this newsletter, you’ll have insight into why the question gets asked. Best of all, you’ll have 4 simple questions you can ask to get… [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…]
The 4 KISS Principles of Computer Validation
If you’re like most people, you resolved to lose weight this year. Eat less; exercise more; lose weight. Simple, right? Yes, but not easy! Computer system validation is like that – there are 4 simple principles behind it. In fact, they’re so simple, I call them Stupid Simple. If you avoid auditing computer systems, listen up!… [Read More…]
Does scanning always result in true copies?
Unfortunately, the answer is no. Yesterday, NBC News reported that Xerox scanners using a compression algorithm called JBIG2 were changing characters during the scanning process. That’s right! 6s randomly become 8s! No worries, you don’t scan anything and hope the scanned version is an exact copy of the original, do you? Of course you do…. [Read More…]
