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…]
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