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…]
But the Instrument Doesn’t Let Us….
…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…]
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…]
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…]
