Articles > 2004

A Software Prescription for FDA Compliance

New electronic signature requirements for medical device manufacturers have led to the release of a number of new software packages, including the release of a statistical process control (SPC) package that meets the standard while offering statistical analysis and enhanced lot geneology.

Did Your SPC Software Forget about the Process?

This article describes the problems encountered when using a single SPC file to collect data from a part that is run on different machines.

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