Larger pharma organizations have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holistic approach to innovation. To meet these myriad demands and retain a competitive edge, life sciences enterprises need to adapt and evolve to deliver more patient-centric innovations.
Getting real value out of the internet of things (IoT) can be viewed as a "perfect storm" in the sense that it presents “a rare combination of circumstances with the potential to result in an event of unusual magnitude.” As science-based organizations look to leverage the IoT within the laboratory careful consideration must be given to available technologies, data formats, and platforms.
Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, the FDA’s recent draft guidance, Request for Quality Metrics, promotes a “quality-driven corporate culture” as one of its goals.
Change control is collaborative, iterative, and labor intensive. This article examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management that spans all areas of the organization and extends throughout the product life cycle.