Continuous compliance: Rather than preparing for audits, agents continuously monitor validation completeness, test coverage, ...

BRIDGEWATER, N.J.-- July 10, 2024--The MIPI Alliance, an international organization that develops interface specifications for mobile and mobile-influenced industries, announced the release of MIPI ...

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...

Hugh Cumming had his work cut out for him. The gap between what his not-yet-implemented call center management application at a large European company could do and the requirements list created by 40 ...

Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. Q. We are a well-established pharmaceutical ...

SDLC guides teams to plan, build, test, and deliver software. Discover phases, KPIs, tools, and checklist with our quick start guide. Picture this: You and your team have spent a tremendous amount of ...

When buying enterprise software, conventional wisdom says that users are the ultimate source of functional requirements. While this seems logical, it is incomplete because, apart from their pain ...