AI-Driven Compliance: The Future of Software Validation in Life Sciences
In the highly regulated world of life sciences, ensuring the safety, efficacy, and reliability of medical products is not just a legal requirement—it’s a moral imperative. Software has become an integral part of pharmaceutical manufacturing, clinical trials, diagnostics, and medical devices. As the complexity of these digital systems grows, so does the challenge of validating them to meet stringent regulatory standards such as FDA 21 CFR Part 11 , GxP , and EU Annex 11 . The traditional manual approach to software validation is time-consuming, expensive, and prone to human error. Enter AI-driven compliance —a transformative solution redefining how life sciences companies validate their software. Future of Software Validation in Life Sciences 🌐 What Is Software Validation in Life Sciences? Software validation is the process of ensuring that a software system performs...