Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation is ...
Hardware emulation continues to prove itself as a handy tool for hardware/software co-verification, where the objective is testing the integration of hardware and software. Part 1 of this series ...
Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...
An electronic object-based approach towards validation is forecasted to be the upcoming validation paradigm supported by reliable web-based technology, organizational focus on risk management and ...
Life Sciences companies require centralized access and control of GxP documents and CAD drawings to improve quality processes and simplify compliance and system validation for FDA 21-CFR Part 11 and ...