Clinical research has been facing some major changes in the last years with the continuous exchange of paper based processes for modern electronic data capture. As a consequence of this step the validation of electronic system has been drawn into focus of audits and inspections. This raises a need for guidelines regulating GCP relevant systems. Alcedis is an active member of the ISPE SIG group for several years. This work resulted in a recently published concept paper which harmonizes GAMP 5 principles and GCP requirement for electronic data capture (EDC) systems in a practical approach. Read the full paper here: The Application of GAMP 5 to the Implementation and Operation of a GxP Compliant Clinical System.