The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...
CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...
Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...
This training unlocks opportunities for companies to modernize GxP validation by shifting to Computer Software Assurance, ensuring data integrity and compliance with FDA regulations, and addressing ...
The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health ...
InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.
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