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Instead of a painful, time-consuming and costly process, what if being audited by the FDA, or any other regulatory body, was just part of the day to day routine? For the MedTech industry this makes perfect sense – it would not only reduce the financial overheads associated with being audited, it would also substantially reduce time and business risk.
Speed, efficiency and effectiveness. These are three very different things but are often associated with each other. According to folklore, the fastest doesn’t always finish first – so is efficiency and effectiveness what you should be striving for? Design of Experiments (DOE) is like this. You can conduct experiments fast, but what if you miss an important interaction because you can only experiment with one factor at a time?