Achieving an end-to-end audit approval from Health Canada
Background
The second COVID-19 project for Alsinova, 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
Alsinova and Health Canada held bi-weekly video meetings, daily communication was increased each day and all parties were copied on all correspondence
Key results
Remote audit was efficiently and effectively conducted
Alsinova passed the audit with no corrective action and with zero notes
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