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Achieving an end-to-end audit approval from Health Canada

Background

The second COVID-19 project for Keyrus Life Science, with a Canadian sponsor was audited by Health Canada because of the rapid approval COVID-19 products were receiving

Challenge

The only way the audit could be performed was remote. Keyrus Life Science and Health Canada had never done a remote audit previously

Approach

Keyrus Life Science and Health Canada held bi-weekly video meetings, daily communication was increased each day and all parties were copied on all correspondence

Key results

01
Remote audit was efficiently and effectively conducted
02
Keyrus Life Science passed the audit with no corrective action and with zero notes
03
The audit was completed in four weeks

Benefits

Working together, Keyrus Life Science and Health Canada were able to achieve their first remote audit while thoroughly reviewing all elements of the Sponsor's COVID-19 project and finalizing without corrective action and with zero notes

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