By Petter Moree, Life Sciences Industry Principal, OSIsoft
The paradigm shift in today’s pharmaceutical industry that has changed the focus from large-scale production blockbuster drugs to niche drugs for smaller patient populations, including personalized medicines, is increasing the need for manufacturers to improve their operational efficiency and flexibility. One concept of doing so through computerized manufacturing was introduced by the ISPE Germany/Austria/Switzerland affiliate as Industry 4.0, which ultimately evolved into the term “Pharma 4.0.”
The digital transformation promoted by this revolution concentrates on optimizing operations and facilitating real-time and better decision-making by leveraging critical data from across a manufacturing network. However, as regulatory requirements for documentation, data integrity, and process validation create growing pressure on companies to remain compliant, many are rushing to adopt advanced technologies and solutions without a holistic plan to implement them. This prevents them from reaping the benefits of connected data, which may become a major factor in remaining competitive in this changing market.