In April 2025, the US Food and Drug Administration (FDA) published a roadmap for leveraging new approach methodologies (NAMs), including in silico approaches such as artificial intelligence (AI), to ...

In today’s digital systems, vast volumes of information are produced daily. However, simply collecting large amounts of data is not enough. That data must be reliable and well-structured to serve any ...

That’s the environment where Venkatesh Kanneganti, a senior IEEE member, and a seasoned Quality Assurance and validation ...

While the open-source Seismometer tool does not provide ROI metrics, it can surface insights on an algorithm's quality and utility, say early users at Michigan Medicine.

Process industry standards historically dictated that a separate platform be used for a safety system. But modern technology now enables fully integrated systems that can handle both the base process ...

The Cleveland-based health system does not shy away from taking time to ensure that an AI tool is a good investment and is the right solution for its patient population.

Explore how cybersecurity innovations are transforming system validation, ensuring compliance, risk mitigation, and operational resilience in the digital era.

For example, AI is covered in the FDA’s Process Validation Guidance, EMA’s Annex 15 on Process Validation, and GMP Annex 11 on Computerized Systems as well as the ICH Q8–Q12 principles for ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...