I have been actively involved in computer system validation activities since 1995 and have witnessed the maturity of validation from the early days of “what does validation mean?” to the current standard of GAMP 5. During the industry shift toward Quality risk management (QRM) that was brought front and center with the FDA’s report “PHARMACEUTICALContinue reading “Validation Is Risk Management”
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Blockchain is Not Your Savior
Blockchain has gotten lots of buzz in the past couple of years, and with the announcement that Amazon (along with other major players) is making it simpler for companies to adopt it, the buzz will only increase. I attended the Paperless Lab Academy in Milan earlier this year, and blockchain was discussed as an emergingContinue reading “Blockchain is Not Your Savior”