FDA Guide for Food Processing Computer Systems

“Guide to inspections of computer systems in the food-processing industry”

issued by FDA CFSAN.

While this guidance applies to the food industry it has useful information on general requirements for computer system validation particularly in the areas of monitoring, alarms, backup and recovery, and shut down recovery.

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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

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