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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...

In the Pharmaceutical and Medical Device industries, document control is an essential quality system element and a regulated requirement because written instructions directly affect processes that impact product quality.