ISPE GAMP R&D and Clinical Systems SIG publish first Concept Paper

Recommendation

23-26 April 2024
Berlin, Germany

Computerised System Validation - Introduction to Risk Management + GAMP 5 Approach
Learn How to Plan, Implement and Document Effectively Computer Validation Activities

As the pharmaceutical industry increasingly transitions from paper-based to computerized processes, the validation of these systems is also becoming a focus of inspections in the field of clinical trials. This has resulted in an increased need for guidances and guidelines concerning GCP-regulated systems, especially since these systems play a crucial role in the life cycle of medicinal products.

Currently, there are only a few guidelines in existence which explicitly address validation activities in the field of GCP. At the same time, there is a paucity of information regarding the practical execution of regulatory requirements. Because the system landscape found in the GCP field is characterized by heterogeneous systems with multiple interfaces and system components of differing complexity and configurability, it is  necessary to find a validation approach that is flexible and scaleable.

GCP experts from the ISPE GAMP R&D and Clinical Systems SIG, led by Q-finity's CEO, have published a Concept Paper with the intention of harmonizing the GAMP 5 validation principles with GCP requirements, using the example of an Electronic Data Capture (EDC) system. The Concept Paper addresses the particular challenges to be dealt with when validating GCP-regulated systems. In the GCP field, there is no tangible product that results from the processes in place. Instead, the "product" is data, which is collected, processed and retained in different system components. Since this data forms the basis for the final analysis of the clinical trial, and with data integrity and patient safety at stake, the systems through which the data flow must be reliable.

By demonstrating the validation approach with a practical example, the application of the GAMP 5 principles to the GCP field are presented in a very comprehensible and concrete fashion.

Author: Oliver Hermann; Q-finity 
More information you will find here:
http://www.q-finity.de/misc/GAMP%20GCP%20Concept-paper.pdf