FDA Unveils New Approach to Software Safety in Life Sciences
The U.S. Food and Drug Administration (FDA) has unveiled a new approach to ensuring the safety and quality of software used in life sciences. On September 24, 2025, the FDA released guidance on Computer Software Assurance (CSA), marking a significant shift from traditional Computer System Validation (CSV) methods.
CSA, first introduced in draft form on September 13, 2022, focuses on risk-based decision making. It prioritises the intended use of software, potential risks to patient safety, and product quality. This approach reduces the need for exhaustive documentation, allowing for more exploratory testing and faster deployment of updates.
The new guidance aligns with modern software development practices such as Agile and DevOps. It encourages critical thinking and leverages contemporary testing methods to streamline validation processes. CSA applies to a wide range of systems, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality Management Systems (QMS), and cloud-based platforms.
The FDA's CSA guidance is more than just a new set of rules; it represents a mindset shift in the life sciences industry. It empowers teams to concentrate on value-added activities, reduce validation fatigue, and accelerate digital transformation. By focusing on risk and patient safety, CSA promises to enhance software quality while facilitating faster innovation.
