Mar 28, 2023 · The GAMP 5 framework provides a structured approach to validation that can be applied to agile development processes. The framework is based on a risk-based approach, …

Sep 18, 2024 · This article explores how to adapt CSV practices to the dynamic nature of agile development, ensuring both quality and compliance without hindering the speed and flexibility …

Feb 28, 2025 · Overall, Agile’s adaptive and automated validation approach leads to faster feedback, reduced risks, and improved software quality, whereas Traditional validation relies …

Nov 12, 2021 · Depending on how complex your project is, you can implement either framework for computer system validation. Kanban and Scrum are the most popular framework. If you …

May 26, 2017 · Where custom coded applications exist, a Waterfall approach prevails as the de-facto strategy to address regulatory compliance requirements. Embracing Agile requires a well …

By applying iterative validation processes and continuous testing, Agile CSV enables faster validation cycles, reduces costs, and affords greater flexibility in adapting to changing …

Understand how to maintain a system in a validated state through the system’s entire life cycle in a more cost-effective manner, applying an Agile continuous validation approach; Learn how to …

To be employed in clinical trials, these tools must undergo a process called computer system validation (CSV) for compliance with Good Clinical Practice (GCP), regulatory and ethical...

Dec 21, 2024 · In a nutshell, the FDA wants life science businesses to invest in computerized systems that digitize, automate and accelerate quality and manufacturing processes. These …

Aug 29, 2024 · This blog post will explore why CSV is misaligned with Agile principles and introduce computer software assurance (CSA) as a superior alternative for Agile validation …