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IN VITRO DIAGNOSTIC QA PLAN SHOULD INCLUDE TREND ANALYSIS

This article was originally published in The Gray Sheet

Executive Summary

IN VITRO DIAGNOSTIC QA PLAN SHOULD INCLUDE TREND ANALYSIS to determine whether there are system failures that can be corrected, FDA's Center for Devices and Radiological Health says in a final draft of the IVD good manufacturing practices guide. Suggesting trend analysis as a way to comply with the requirements of the GMP regulation, FDA says that "product and process accept/reject data results, along with information from complaint files collected through various documented process and control systems, are evaluated by appropriate methods (e.g., trend analysis) to determine if there are recurring problems or process drift which warrant corrective action."

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