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 ...

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 ...

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 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 ...

The Keysight AI Software Integrity Builder enables validation and lifecycle maintenance of AI-enabled systems to ensure ...

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 ...

Computer software assurance (CSA), the FDA's new framework for computer system validation (CSV), is being heralded as a game-changer. While the promise of simplified, less costly validation 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 ...

The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often ...