Case Study
The evolving role of the GxP Archivist:
The evolving role of the GxP Archivist: ensuring data protection and integrity among the changing demands new technologies bring Stuart Ward, Bob McDowall and Damien Tiller Customers and regulators expect the highest level of data integrity, and many organizations rely on an archivist to maintain and protect this most important asset. www.idbs.com1 www.idbs.com 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 respo