The emergence of Pharma 4.0 is bringing dramatic and positive changes to the life sciences. The
advent of new and highly complex therapies presents new challenges to emerging companies,
which are challenged with limited staff, a need for speed to market, and limited funding.
To manage and survive these challenges, companies need to be part of a “cyber-physical” system or
ecosystem that includes partnering with service providers as part of the overall supply chain.
Building on the growing need for real-time high transparency and real-time data access, with a
high level of data integrity, Pharma 4.0 brings a significant move to the digitization of all
components related to performing real-time business and process improvement. This change is so significant that the FDA has
generated a memorandum of understanding to drive the industry to Pharma 4.0, as well as encouraging the incorporation and
implementation of advanced manufacturing techniques (AMT), such as continuous manufacturing.

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