This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...

May 7, 2024 --Siemens Digital Industries Software today introduced Solido™ IP Validation Suite software, a comprehensive, automated signoff solution for quality assurance across all design ...

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 ...

In an age where software drives nearly every aspect of daily life, ensuring its quality at scale has never been more essential. In 2024 alone, global IT spent over $5.1 trillion in expenditures, and ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

Software testing, verification and validation form the backbone of modern software quality assurance. These interrelated activities ensure that a software system accurately implements its intended ...

The present publication provides for the first time information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety.

The real “pain point” for providers should be inadequate systems, not quality oversight. I’m referring to Kimberly Marselas’ recent article that portrays the Center for Medicare & Medicaid Services’ ...