I am thrilled to introduce Quality Digest’s special report, “Unlocking the Future of Life Sciences.” This series explores the last several decades of quality management within the life sciences industry. It begins with the genesis of early regulations, shows us how that led to the current state of quality, and offers a glimpse of what we can expect during the next five to 10 years. As someone who has lived and breathed quality for nearly three decades, I have never been as excited as I am today about the current state of quality management and the pivotal, vital, and valuable role it will play going forward.

Industry 4.0 and its underlying technologies are ushering in greater connectivity and interoperability, both within companies and across value chains. At the same time, within healthcare, the explosion of personalized care, medicines, and devices—among countless other innovations—has put the patient at the center of the everything. This presents extraordinary opportunities, but it also brings significant challenges around quality and compliance.

Those of you who manage quality will need to balance the tension between ensuring the quality, safety, efficacy, compliance, and continuity of supply alongside the need to innovate at breakneck speeds. Those of us who develop quality management solutions will need to reimagine them altogether to enable and facilitate this transformation. And together I know we will positively affect the health and wellness of the global population. It’s no longer a question of if, but a matter of when.  

And if the findings of Sparta Systems’ recent report, “2019 Pharma Quality Outlook” are any indication, the next evolution of quality is already well underway. Every passing year, more of you are making economic performance a top objective and anticipate using data to improve said performance. Meanwhile, during the next year and a half, 43 percent of you will evaluate or experiment with Quality 4.0 technologies.

So, I leave you with this parting thought. In 2009, Sir Tim Berners-Lee, one of the inventors of the world wide web, was quoted as saying, “The web as I envisaged it, we have not seen it yet. The future is still so much bigger than the past.” Perhaps he’d already had some inkling about where the web would be a mere decade later. Similarly, I invite you to reflect upon life science quality management over the past several decades, and boldly imagine the bright new future ahead of us.