To meet FDA and other regulations, pharmaceutical and biotech companies must be able to manage data to show evidence of compliance while accelerating time to market. Companies face increasing frequency and duration of audits, regulatory warnings and consent decrees. Though regulations keep changing, the last few years of transformation in the pharma/bio industry haven’t minimized the continuous pressures on pharma/bio organizations to innovate and grow. Companies are addressing these pressures with familiar tools and strategies namely M&As, expansion through biologics, outsourcing and advanced technology/digital capabilities. What has changed, however, is the way in which organizations are leveraging these tools across the enterprise and outside the traditional four walls.
Ever-growing margin pressures and increased financial scrutiny are forcing manufacturers to innovate and re-conceptualize even the most elemental business functions, requiring new technologies and business partnerships. As manufacturers prepare to meet regulatory requirements around serialization, (2017 Drug Supply Chain Security Act) key components for enterprise visibility will require systems/data integration and more collaboration. End-to-end quality management throughout the product value chain is now a necessity to increase the speed to market, and protect both companies and patient safety while meeting increasingly complex regulatory demands.