With more than 40 years of experience in the pharmaceutical and healthcare industry Peter Gough from NSF presents a whitepaper on data quality risk management
Risk is a familiar concept. We take risks all the time. Even the act of driving to work carries some risk. It is important to understand that in life no activity can ever be totally risk free.
The advent of the FDA’s twenty-first century GMP and other initiatives have turned a spotlight on to how we manage quality risks in the pharmaceutical industry.
Other industries, including closely related ones like the medical devices and food industries, have adopted a more structured approach to this subject than we have traditionally used.
NSF's approach to assessing and controlling quality risks have largely been empirical.
This is often fine, but in more complex or hazardous situations there are a number of very helpful tools and techniques that the pharmaceutical industry has mostly ignored.
To find out more about this topic, download the following whitepaper.