Pharma 4.0 has been developed by industry professionals who understand the unique compliance challenges of pharma. The focus of Pharma 4.0 is on incorporating the latest technological advancements within data acquisition, warehousing, analytics, visualization into such a regulated environment. Regular, repetitive tasks that require absolute precision are automated, based on real production data. Automated production systems, sensors and analytics prevent human error and standardize procedures for absolute precision in every batch. This optimizes batch consistency and enables right first time execution. The fully-integrated network of systems, equipment, and instruments communicate with one another to eliminate potential for errors. Systems communicate with one another to define action, based on real conditions and events. Such an approach can significantly mitigate the risks associated with retroactive and post-mortem investigation and discovery.
Data silos cease to be an issue as all information is instantly aggregated and available in real-time. End-to-end visibility drives increased cooperation across the value stream to lead targeted and data driven improvement. A truly efficient digital facility requires a fully-integrated suite of interconnected technology that achieves process harmonization while maintaining regulatory compliance.
Oftentimes, paper-based documentation requires wet signatures for authorizations, which can impact production speeds and time to market. With the degree of data availability provided within a Pharma 4.0 framework, electronic signatures can significantly accelerate the review and authorization process, without compromising production and regulatory requirements. As such, eliminating the need to send documents from one location to another and providing hand-written signatures.
Pharma 4.0 is the future of the pharmaceutical industry. Never before have the life sciences had access to the levels of precision and ease of communication available today. The days of paper-based documents and manual, hand-written data entry are a thing of the past – and with them goes input errors, illegible handwriting, and long-term management resources for the physical documents. Interconnectivity within and across industries is creating more efficient methods of sharing information in real-time to promote cooperation and collaboration across time zones and geographic location.