One of the challenges for young organizations is developing a “feel” for quality. It’s a subjective thing. After participating in activities done well, you develop a rhythm-an inner sense that things are flowing as they should (or not). Call it a “gut feel” if you will. One of those “gut feel” items that I lookContinue reading “Quality is Front-Loaded”
Tag Archives: #validation
Validation Is Risk Management
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”