Validation and Compliance of Computerized GCP Systems and Data, second edition has been published by the ISPE. The guide covers a process overview and process model of GCP systems, data integrity, data privacy in clinical trials, decentralized clinical trials, assessment of clinical trial site systems, good clinical laboratory practice, use of data science and AI-enabled systems in clinical trials, real-world data/real-world experience, and open-source software in clinical trials. You can buy your copy from the ISPE website.
top of page
- Apr 16, 2024
Join us at the next GAMP CoP UK Forum, 23-Apr-2024 in Wilmslow. Topics will include using SaaS - GxP Study considering Benefits and Risks, Virtual Audits, Project Execution Tools, and Risk Based Testing. Register to attend via the ISPE website
- Mar 12, 2024
The next GAMP Computer Software Assurance (CSA) Special Interest Group (SIG) meeting will be on 13 March 2024. Join us in participating in the session where the topic of the meeting is CSA Use for Manufacturing Systems.
bottom of page