A complete, audit-ready Computer System Validation (CSV) portfolio project. Demonstrates the full validation lifecycle per FDA 21 CFR Part 11 and GAMP 5 for a mock clinical trial system, including URS ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...

Regulation and the pharmaceutical sector are intrinsically linked. Indeed, it’s no exaggeration to state that the global pharmaceutical sector is one of the most heavily regulated industries in the ...

The medical device industry stands at the convergence of innovative design and stringent regulatory requirements, where design quality engineering serves as the critical bridge between conceptual ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global enterprises operating under the scrutiny of the FDA, EMA, and other regulatory ...

Abstract: The Verification and Validation (V&V) processes are used to determine whether the development products of a given activity conform to the requirements of that activity and whether the ...

Federal officials are scrambling to assess the damage and address flaws in a sprawling, heavily used computer system long known to have vulnerabilities. By Adam Goldman Glenn Thrush and Mattathias ...

With digital data being stored in varieties of devices, the Finance Ministry will be widening the definition of the ‘computer system’ under the new Income Tax Bill 2025 and the Central Board of Direct ...

Alqemam 2024 profit dips 51% to SAR 9.3M; H2 at SAR 4.7M 12 M 2024 Alqemam reports H1 2024 profit at SAR 4.6M 6 M 2024 ...