A new QMS framework is needed to create a seamless, one version of truth across the organization, injecting heightened effectiveness and efficiency into the industry quality processes.
This framework creates a mechanism for companies to quickly and safely tap into a variety of data streams (deviations, CAPAs, complaints, audits and change control) and use analytics to drive better decision-making, faster issue resolution and improved compliance.
EY has designed a step-by-step quality excellence framework to help companies build consistent QMS programs across sites as well as at the corporate level. It is a multiyear journey that requires significant leadership support, cross-functional collaboration and a "quality is what we do" mindset.
Companies should run small pilots to identify where and what in the organization to do first. They should look for quick wins that help create momentum and fuel future transformation efforts and, possibly, unlock funds to reinvest in long-term business needs. Agility will become a core strength among winning pharma firms.
Achieving quality excellence in any organization is not an option — it is a strategic must. As the industry makes strides toward securing value through data-driven platforms, integrated quality management systems will continue to play an integral role in the journey — providing better and timelier information that is drawn from a multitude of sources and consolidated to provide intelligent decision support.
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