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 ...

The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized ...

InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

Join us for an insightful webinar that explores the shifting paradigms of software development, validation, and system maintenance in a continuously changing environment. This session will offer a ...

Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Risk-based Computer System Validation; Reduce Costs and Avoid 483s (ONLINE EVENT: August 6-7, 2025)" has been added to ResearchAndMarkets.com's offering.

DUBLIN--(BUSINESS WIRE)--The "Computer System Validation (CSV) Training Course (Sept 23rd - Sept 25th, 2025)" training has been added to ResearchAndMarkets.com's offering. The attendee will learn ...

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 ...

The system employs HMAC-SHA256 (Hash-based Message Authentication Code using SHA-256) for license integrity verification. SHA-256 refers to the Secure Hash Algorithm producing 256-bit hash values (see ...