October 21, 2013 – ISPE GAMP R&D and Clinical Systems SIG are publishing first concept paper

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.