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 is a significant part of any modern manufacturing operation, and FDA requires validation of such software used for regulated processes. Companies are often confused, however, about when and ...

Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction. Within pharmaceutical manufacturing, the goal of process ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Birgitta Böckeler, Distinguished Engineer at ...

General Dynamics Chairman and CEO Phebe Novakovic told investors and analysts during an earnings call last week that the company’s efforts to obtain type certification on the Gulfstream G700 in ...

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 ...

SALT LAKE CITY, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Today, MasterControl, a leading provider of quality management and next generation manufacturing execution software, announced Validation on Demand is ...

SALT LAKE CITY--(BUSINESS WIRE)--MasterControl Inc., a leading global provider of software solutions that enable life science and other regulated companies to deliver life-improving products to more ...

One of my more aspirational career goals has been to increase the efficiency of validation testing without lowering the quality. Testing of automated systems is essential to ensure quality in both the ...

A certification flight required to clear the grounding on the 737 MAX is awaiting software validation, with Boeing CEO Dave Calhoun anticipating a third quarter return to service, according to the ...