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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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