The Evolving Role Of The GxP Archivist

By Stuart Ward, Bob McDowall, Damien Tiller

This need to protect the data encompasses intellectual property and/or regulatory data integral for marketing submissions. Therefore, ensuring the archivist can guarantee adequate protection and control for regulatory data is critical for organizations to meet their business goals. According to the AGIT Guidelines for the Archiving of Electronic Raw Data in a GLP Environment published in 2018, “the archivist is responsible for all aspects of electronic archiving and should have full control of all activities within the archiving process. If there is external IT involvement (e.g. a service provider), the
archivist has to ensure that the procedures are followed as described in the relevant service level agreements or contracts.”

But will regulators accept the storage of Good Laboratory Practice (GLP) data using cloud technology?

This white paper will assert that storing GLP data in the cloud is acceptable, provided certain conditions are met.