2 minute read 5 Mar 2019
Female scientist with filters, inspecting a laser lens in a laboratory

How to build holistic integrated quality systems in LS organizations

By

EY Americas

Multidisciplinary professional services organization

2 minute read 5 Mar 2019

A new quality management systems framework is needed to create one version of truth across the life sciences organization.

Within  life sciences, there has been a paradigm shift from product-centric business models to data-centric models tied to improved health outcomes. This is driving substantial disruption and subsequent transformation across the value chain.

Rapid technological advances and the ubiquity of mobile platforms have created new opportunities for value creation. The result is a dramatic increase in the velocity, variety and volume of data to personalize and promote customer engagement.

As the pace of change continues to accelerate, the companies most likely to succeed are those that can intelligently work with data to predict key market trends. As such, data literacy is essential to moving from managing data to using it to make business decisions. Future success will be measured by the ability to find common ground to meet differing stakeholder demands, thereby creating trusted relationships.

Even as life sciences companies embed digital, data-driven tools into their clinical trials and commercial activities, they haven’t put the same emphasis on their quality management systems (QMS), which is essential to deliver safe and effective products to customers and achieve competitive advantage.

Organizations face challenges to define and deploy an integrated QMS across the value chain for effective quality and compliance management.

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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Summary

Within life sciences, there has been a shift from product-centric business models to data-centric models tied to improved health outcomes. As the pace of change continues to accelerate, the companies most likely to succeed are those that can intelligently work with data to predict key market trends.

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By

EY Americas

Multidisciplinary professional services organization