Recording of the three-day boot camp led by Carolyn Troiano covers CSV versus Computer Software Assurance, SaaS and cloud validation, risk assessment, IQ/OQ/PQ protocols, ALCOA+ data integrity, vendor ...

Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment. This session will offer a ...

Computer software assurance (CSA) is now FDA's recommended framework for validating production and quality system software, replacing the documentation-heavy computer system validation (CSV) model ...

Software is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and ...

Zifo, a leading global enabler of AI and data-driven enterprise informatics for science-driven organizations, announced the ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Learning how to write a lab instrument validation plan for an AI tool means adapting a familiar structure to an unfamiliar problem: software that updates, retrains, and produces probabilistic outputs.