…use access controls…implement audit trails… 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.” Here are Counters… [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…]
Getting to “Yes” on Audit Findings
Have you ever written an audit finding only to get back the following response? “This is not a finding…” Most of us have at one time or another. I think we can all agree it’s not a good feeling. Here are 2 tips to help you eliminate this response. 1. The exit meeting is not… [Read More…]
How Do I Apply ALCOA To E-Records?
It’s easier than you think! Let’s Start with a paper record example Explore how to apply ALCOA to electronic records Point out 3 warning signs on the trail to data integrity ALCOA in the paper world ALCOA defines the generally accepted standard for GLP and GCP data quality and data integrity. Let’s use paper CRFs at a clinical investigator’s… [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…]
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 the electronic records. But we hear rumblings from GMP inspections that FDA doesn’t always share that view (see Finding 4). What are the 2 keys? 1. Content 2…. [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…]
