Innovations in the application of Good Laboratory Practice (GLP) auditing practices on field studies are rare. However, during the unprecedented COVID-19 travel and remote working restrictions imposed in 2020, it was necessary to use new approaches to conduct GLP quality assurance (QA) audits on field studies. This presentation will highlight the use of innovative remote digital techniques to allow field tasks and activities to be audited without the need for the GLP QA auditor to be present in person. The regulatory acceptance of the new methods will be discussed, lessons learned, in addition to the broad spectrum of situations to which this new technique could be applied.

Remote Auditing: A case study on the innovative use of remote quality assurance audits to ensure the compliance of multi-site GLP studies during pandemic travel restrictions

ACS Fall 2021

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