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 ...

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 ...

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 ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

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 ...

Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with content, and download exclusive resources. Cory Benfield discusses the evolution of ...

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 ...

Regulators are modernizing their expectations, and it's become clear that validation can no longer function as a point-in-time event.

The rate of technological advancement is increasing faster than ever before. Although the demands for meeting aggressive time-to-market requirements and innovating at warp speed are not new, they are ...

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 ...