On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Non-compliance issues show that users find dealing with computer systems challenging. Quality management of computer systems (hardware and software) is a central part of the overall quality management ...

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 ...

This seminar will provide an overview and in-depth snapshot of the process for managing V&V activities affecting product, process, equipment and the QMS. Company employees responsible for new product ...

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 ...

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 ...

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 ...

In today's fast-moving world of vaccines, gene therapies and biotherapeutics, computerized systems play a critical role in the discovery, manufacture and delivery of potentially life-saving drugs.

General Motors is sliding into a quagmire of software issues. Having previously issued a stop sale of its brand-new Chevy Blazer electric SUV over related concerns, it is now holding back deliveries ...