In a previous article we looked at the emergence of MTP 4.0 (Industry 4.0 for the Medical Technology, Biotechnology and Pharmaceutical sector) as a holistic operating model to facilitate an agile development and manufacturing environment for the near future.
Being holistic, the operating model covers all aspects of the business, using a digital...
When handling a pharmaceutical or medical device, it is imperative in the eyes of the regulator, such as the TGA or FDA, that people within your organisation are assigned appropriate roles and responsibilities. One of the most important roles is that of the Authorised Person, who is responsible for authorising steps of the manufacturing process,...
Your quality systems and procedures are in place, however no matter how much you try, people still don’t fully comply with them. These deviations and subsequent investigations lead to lost productivity. Typically you identify “human error” as the root cause and your corrective action is to train your team.
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