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