I recently discovered a gap in my education. Like you, I’ve seen my share of redacted 483s and EIRs. Those redations are marked with a “(b)” followed by a number in parentheses. I’m normally a curious person, but it never occurred to me those letters and numbers had a meaning. I had an aha (and… [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…]
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…]
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…]
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…]
