Computer Software Assurance: Defining Critical-to-Quality Requirements for GxP Systems

digi — Sat, 15 Nov 2025 03:56:47 +0000

Computer Software Assurance: Defining Critical-to-Quality Requirements for GxP Systems Implementing Computer Software Assurance through Defining Critical-to-Quality Requirements in GxP Systems In the pharmaceutical industry, compliance with Good Manufacturing Practices (GMP) necessitates rigorous oversight and assurance of computerized systems. Computer software assurance (CSA) is an evolving approach that emphasizes a risk-based, science-driven methodology to verify that...

CTQ requirements;critical functions;CSA;requirements quality;CSV – Pharma GMP

Computer Software Assurance: Defining Critical-to-Quality Requirements for GxP Systems