Publication of GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data

The ISPE has just published the second edition of the GAMP Good Practice Guide (GPG): Validation and Compliance of Computerized GCP Systems and Data. QFINITY employees were part of the team that worked on this edition. The content has been significantly expanded, making this the most comprehensive guide to computerized clinical systems and data currently available.

The first edition was published in 2017. This update was necessary as significant advances have been made in the conduct of clinical trials in recent years. Some of these changes, such as decentralized clinical trials, have been accelerated by the COVID-19 pandemic. The changes in the industry have also prompted regulators to issue guidance such as the EMA’s “Guideline on computerized systems and electronic data in clinical trials” and the “Notice to sponsors on the validation and qualification of computerized systems for clinical trials”, which have been taken into account when updating the guide. The content was also significantly expanded to include information on real world data / real world evidence, data protection in clinical trials, artificial intelligence and data science, and decentralized clinical trials. Last but not least, the guide had to be adapted to the 2nd edition of GAMP 5.

More information about the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data can be found here.