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Picture of Don Zinn, Practice Director, Validation

Don Zinn, Practice Director, Validation

Quality & Validation Technology Insights

A Timely Part 11 FDA Draft Guidance for Systems Validation for Clinical Trials Development

The use of electronic records in clinical research is growing in practice and complexity for Sponsors, investigators, IRBs and CROs. As a response to that growth in 2017, the FDA issued...

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