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Regulatory compliance cannot be an afterthought when you apply artificial intelligence, machine learning, and other advanced information technologies to biopharmaceutical development and manufacturing. The authors in this eBook encourage readers to keep product quality (as well as business concerns) in mind, using agile methodologies and good automated manufacturing practices while embracing the bioprocess 4.0 paradigm. As the industry takes its IT to the next level, smart planning and critical thinking are vital to success.  First, the editor in chief highlights issues related to cybersecurity. Then, authors from PGE Group illustrate how GAMP 5 and agile/critical thinking apply to computer system validation — and why they are important to product quality. Nick Anderson encourages companies to apply lessons learned from pandemic collaborations toward a cooperative approach to supply chain logistics in a postpandemic world. Roger-Marc Nicoud urges an engineering approach to bioprocess simulation strategy. And finally, another set of authors from PGE Group demonstrate how validation is important for artificial intelligence and machine-learning applications.

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