Market opportunities arise in providing solutions for cGMP software verification and validation, addressing increased FDA scrutiny. Demand exists for expertise in FDA guidelines, risk management ...

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, ...

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 ...

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 ...

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 ...

Imperas Software Ltd., the leader in high-performance software simulation and virtual platforms, and Test and Verification Solutions (T&VS), a leading hardware verification and software testing ...

Medical device manufacturers need to validate any off-the-shelf software on which their products rely—with or without the software vendor's cooperation. So says FDA in a new draft guidance issued in ...

If you would like to learn more about the IAEA’s work, sign up for our weekly updates containing our most important news, multimedia and more. This report provides practical guidance on the methods ...