…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…]
When is a CRO not a CRO?
(And why does that make enforcement hard?) What do the following companies have in common? Electronic data capture (EDC) software providers Central image / electrocardiogram (ECG) / spirometry readers Central clinical labs Electronic patient reported outcome (ePRO) software providers They’re not Clinical Research Organizations. That’s right. They’re not CROs. When you finish this, you’ll be… [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…]
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…]
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…]
5 Questions You Should Ask Your GLP & GCP Labs (and the answers you need to know)
1. What are the records? Records include more than the final assay results. For example, they can include audit trails, QC results, user access control lists, and configuration settings. Review the manufacturers’ user and administrator manuals to identify records the instruments create, modify, maintain, or transmit. Ask for a guided tour of the validation / qualification… [Read More…]
