Join our Computer System Validation Boot Camp to master FDA regulations, including 21 CFR Part 11, and gain hands-on experience in validation projects. Register to secure training materials, live ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

Get insights into the key differences between CSA and regular risk assessment for computer software validation, and why CSA leads to streamlined, risk-based validation.

Effective and compliant computer system validation is critical to any FDA-regulated organization. FDA has set forth very specific requirements for meeting compliance, and a very prescriptive set ...

Harvard’s Computer Science department debuted a new course this semester — COMPSCI 1060: “Software Engineering with Generative AI” — an applied engineering course in which students use ...

Computer Software Assurance (CSA) is a development from the Food and Drug Administration (FDA) Case for Quality initiative that was purported by industry proponents to replace Computerized System ...

Epic plans to release an AI validation software suite to enable healthcare organizations to evaluate AI models and monitor those systems over time.

FDA defines a computer system as a “functional unit of one or more computers and input/output devices, peripherals and associated software, used in common for all or part of a program and storing all ...

Software verification and validation (V&V) processes determine whether the development products of a given activity conform to the requirements of that activity and whether the software satisfies its ...