Introduction to the ISPE Good Practice Guide Validation and Compliance of Computerized GCP Systems and Data

Recently released regulatory guidance documents and the release of the ISPE GAMP® 5 Second Edition have triggered an update of the ISPE GAMP® Good Practice Guide “Validation and Compliance of Computerized GCP systems and Data”. Maintaining the principles and framework of the First Edition, GAMP® Good Practice Guide has been revised and expanded in 2024 to address quality, integrity and compliance aspects, such as:

• AI/ML Systems in Clinical Trails
• Systems at Clinical Sites
• Systems in Decentralized Clinical Trials
• Real-World Data / Real-World Evidence
• Audits and Inspection Readiness in an Outsourced Environment
• Systems involved Good Clinical Laboratory Practice