Bridging the Gap to Quality 4.0

Bridging the Gap to Quality 4.0

Larry Ferrere, Senior Director of Business Marketing, Pilgrim Quality Solutions, an IQVIA company

It is still amazing to me the number of companies that are managing their quality and operating in SharePoint, Excel, and with paper-based SOPs and disparate systems. Thus, it shouldn’t surprise me, but it does, that so many companies do not know the level of their Quality Maturity or their Cost Of Quality. If they say they do know, they inevitably over-rate themselves as much more mature than the norm or where they truly are, and they understate their total Cost Of Quality.

The Cost of Quality

LNS Research, after extensive surveying of companies in the life sciences market, has found that the majority are at Level 2 Controlled maturity, or at the low-end of Level 3 Proactive maturity, on the 5-tier Quality Maturity scale. The implications are profound.

The total Cost Of Quality (COQ) for companies operating at a composite Level 2 maturity could be as much as 18-24% of revenue; those same companies, however, have the ability to save 6-7% simply by improving one level on the maturity scale! For a $250 million company, that’s a $3 million COQ improvement.

With this type of bottom-line financial savings, and the benefits of a harmonized enterprise quality management solution (EQMS) in the cloud, why is this not the top priority of every executive? And why, too, would anyone risk the compliance ramifications of not implementing an enterprise-wide QMS to manage their end-to-end quality and regulatory compliance needs?

Advanced Quality Solutions

Of course, there are many other reasons to look to improving and harmonizing one’s quality processes. Leading companies are looking beyond traditional quality to leverage Industry 4.0 and Quality 4.0 principles and initiatives. However, we believe that traditional quality solutions do not provide the proper or adequate foundation to enable companies to meet their Quality 4.0 goals. One will need what LNS Research calls “advanced QMS” solutions.

EQMS 4.0 - LNS Research

We agree. We believe the gap between Industry 4.0 and Quality 4.0 can be effectively bridged with next generation enterprise quality management, or EQM 4.0 solutions. These advanced QMS solutions go well beyond traditional quality alternatives, both architecturally and data-wise, and integrate seamlessly with other systems.

They incorporate in-the-box industry best practices and regulatory compliant reporting and workflows and heat maps, yet are highly configurable without code modification. They leverage the power of the Cloud; they incorporate artificial intelligence algorithms; they include Supplier Quality Management reach and processes beyond the enterprise; and, they leverage predictive and risk-based management as part of the core EQMS 4.0 platform.

A Bridge to Support the Journey

As the industry leading provider of EQMS 4.0 Quality and Compliance Platform and Solutions, and as an IQVIA company, Pilgrim Quality Solutions is ready to help life science companies with their end-to-end “molecule or concept to market” quality, safety, regulatory, and compliance needs. Contact us to learn more about SmartSolve®, Pilgrim’s Enterprise Quality Management Solution, and how it can help your organization make the journey to Quality 4.0.


EQMS and Quality 4.0

LNS Research examines the evolution of Quality 4.0 and the role an enterprise quality management system plays in its success.

EQMS and Quality 4.0


Pilgrim Quality Solutions

Pilgrim pioneered quality management software more than 25 years ago for regulated enterprises that needed a better way to deliver, track and oversee quality-related activities.

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