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 ...

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. JohanSwanepoel - Stock.Adobe.com Editor’s Note: This article ...

In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...

With car companies adding more cameras, digital display screens, active safety systems and other technology to their vehicles with each passing year, they are starting to rely more and more on ...

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation. The exact state of computer software validation (CSV) can be tricky to ...