I have published an article on the Computer Systems Validation web site (www.csv-qa.com) for performing Failure Mode Effect Analysis (FMEA) for automation and process control equipment.
This article provides an introduction to performing a FMEA risk assessment for computer system validation as part of a quality risk management process.
The process details application of the approach included in GAMP 5 for performing a risk assessment along with some techniques to ensire that all the hazards are identified.
I hope that you find the article of interest, comments and suggestions relating the FMEA for Computer Systems article are welcome; please publish them on this blog.
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