Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it was no surprise that nearly one-third of all presentation proposals for this year’s ISPE Annual Meeting involved DT topics. It is a testament to the breadth of DT that there are three ISPE Communities of Practice (CoPs) operating in this space, each of whom had submitted high-quality...
Across every industry today, digitalization is driving the use and value of data to disrupt traditional business models and ways of working. In pharmaceuticals, the promises of Industry 4.0 are expected, and needed, to finally modernize the legacy approaches that have evolved since the 1970s. Validation is an obvious target for digital disruption because of the inefficient, document-heavy...
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to...