A Guide to Archiving of Electronic Records

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Focusing on compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP), the book addresses the essential retention and archiving of study materials and records. It emphasizes the importance of maintaining both electronic and physical records for reconstruction and verification of studies and trials. The text outlines the operational requirements for archiving, highlighting the unique challenges posed by electronic records and offering guidance on how to effectively manage these issues to meet regulatory and business standards.