For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Vivek Yadav, an engineering manager from ...

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 ...

From my product development experiences, entering into Design Verification and Design Validation is always bittersweet. Exciting because yes, to get to Design Verification means that we have ...

Every product has defects. Finding them as early in the development process as possible is definitely something to strive for. Building quality into software as it's being developed is far more ...

If chip design had a face, it would have a wrinkle or two, an especially deep one caused by the increasingly complex challenge of hardware and software verification. Until recently, these two elements ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Medical device companies, especially those with real-time embedded-system products, are often burdened with lengthy verification cycles. Even small development efforts can result in months of ...

A key focus of the IC design industry is to deliver first-pass silicon, which means finding most, if not all, of the potential defects before tape-out. This is extremely difficult due to increasing ...