September 19, 2014 – ISPE GAMP R&D and Clinical Systems SIG are publishing second concept paper “Validation and Data Integrity in eClinical Platforms”

The validation of electronic system for data capture is a central issue in clinical research for quite some time and is increasingly 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. Now the second concept paper on “Validation and Data Integrity in e-Clinical Platform” was published.