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