Comments on the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, Part 2.

The article discusses the risk assessment methodology used in the validation of laboratory computerized systems in the U.S. According to the author, the modified Failure Mode Effect Analysis (FMEA) risk assessment methodology has been used in most laboratory systems in the Good Practice Guide. FMEA was originally designed for aeroplane designs and was further developed to cover new designs and process.