Moorpark, CA – Jamie Colgin, President of Colgin Consulting, Inc. announced today that she has been named to the inaugural “2017 Distinguished Speaker Inventory” by the Society of Quality Assurance Learning Foundation. Jamie Colgin is an award-winning, formally trained educator who shares vital information on data integrity in clinical trials and the latest compliance and quality… [Read More…]
The Secret Life of (b)s
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…]
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