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URS: A Cornerstone in CSV of GMP Systems

F_Crins10 months ago05 mins mins

In the dynamic and regulated world of pharmaceutical manufacturing, ensuring compliance with Good Manufacturing Practices (GMP) is non-negotiable. At the heart of these practices lies the importance of Computer System Validation (CSV), which ensures that all computer systems used in manufacturing and quality control are reliable, accurate, and consistent. Within this framework, User Requirements Specifications…

Design Specifications (DS) vs. User Requirements Specifications (URS) in a GMP Environment

F_Crins9 months ago04 mins mins

In Good Manufacturing Practices (GMP) environment, ensuring that systems and equipment meet regulatory standards is critical. Two pivotal documents that play significant roles in this process are the Design Specification (DS) and the User Requirements Specification (URS). While both are essential, they serve distinct purposes and are developed at different stages of a project. What…