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Published: December 2017
The ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide a risk-based approach to validating diverse computerized GCP systems in compliance with applicable regulations.
Clinical studies have become increasingly complex due to the emergence of new technologies, such as “wearable” devices, escalating cost pressures and regulatory requirements, and diverse computerized systems that support clinical trials across multiple organizations. A new model of virtually-integrated drug development is needed.
In a structured way, this ISPE GAMP® Good Practice Guide discusses the processes involved in clinical studies, highlighting the unique challenges to collecting data by investigators that is later processed and analyzed by sponsors and/or CROs. It then provides validation approaches for the varied systems used in each process. Additionally, suggestions are offered for developing common systems applicable to multiple studies to minimize customization while meeting the unique needs of the individual project that is a clinical study.
This document is intended to adapt the general principles of ISPE GAMP® 5 to the field of GCP by addressing GCP national and international regulatory requirements. It provides users with a consistent and standardized approach to the application of the risk-based validation approach and principles to processes and their supporting computerized systems with a special emphasis on data integrity and data-flows.