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A holistic, next-generation validation approach for IT GxP systems
Written by Nagendra Kumar J, Peter Klemm and Sjaak Jacobs
24 May, 2024
In our latest whitepaper, Cognizant delves into the realm of IT GxP systems with a pioneering approach to holistic validation. We unveil the intricacies and nuances of next-generation validation methodologies for the life sciences industry and discuss:
• The traditional CSV approach
• The benefits of a holistic next-generation validation approach
• How to optimize, modernize and establish “future-ready” processes, technologies, and the upskilling of work forces
Below you can find the executive summary. The full whitepaper can be read here.
Executive summary
The life sciences industry faces regulations requiring Validation programs for their processes, systems, and equipment. Computerized Systems Validation (CSV) and Computer Software Assurance (CSA) ensure consistent and reliable performance, with modern systems playing a bigger role in business processes and data management.
Despite stringent regulations, the industry seeks new CSV and CSA paradigms leveraging technology to reduce manual effort and accelerate Validation life cycle.
Global and local regulations for the life sciences industry require Validation programs to demonstrate that their procedures, processes, equipment, materials, and systems yield the intended results. Computerized Systems Validation (CSV) is the formal process used to ensure that computerized systems with impact on product quality and patient health are performing consistently and reliably as per design, with end-to-end traceability and data integrity.
As the life sciences sector seeks faster drug development and streamlined regulatory submissions due to market and cost pressures, modern computerized systems play a more and more prominent role. These systems digitally transform business processes, optimize legacy technologies, automate processes, and enhance data management and analysis through leading-edge software engineering methods.
In this whitepaper, we will explore the drawbacks of holding onto traditional CSV, and how to overcome challenges to implement more effective processes. The Validation of IT GxP systems in life sciences, in particular, is crucial to ensure Compliance, reliability and safety in regulated environments. A holistic next-generation Validation approach for these systems integrates various methodologies, technologies and principles to enhance efficiency, accuracy and adaptability.
