The workshop has been designed to provide practical training and guidance to those responsible for the management and operation of a GCP-regulated archive or those who need to improve their knowledge and understanding about this topic. The programme defines what constitutes an archive and the specific regulatory requirements which apply to such facilities, highlighting any differences where they exist between different regulations. Delegates will understand how the principles described apply both to the management of traditional physical records (e.g. paper, tissues, biological samples) and to digital records. The workshop will be interactive, with delegates being encouraged to participate in discussions.