The global life sciences industry is rapidly focusing beyond a culture of compliance to a culture of quality.
Fundamental to this shift is a manufacturer’s ability to provide regulators and executives with greater visibility into its operations and quality processes.
The FDA and other regulators have enacted new regulations and guidance to drive manufacturers to establish systems and processes that proactively identify and prevent issues. Many of these changes require that manufacturers make substantial changes to their quality systems.
Here are the six quality system success factors that are necessary to meet the evolving regulatory landscape.
Want to learn more? For more information about how regulatory changes will impact the industry and how quality teams can prepare—Download “How Evolving Regulatory Pressure Will Impact Emerging Life Science Companies” white paper.