…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…]
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…]
