Is CAPA Enough for Pharmaceutical Compliance?

The pharmaceutical industry faces many challenges, but one that separates it from others is the scope and scrutiny of its regulatory framework. Because the products produced by these companies so directly impact the health and well-being of patients, government agencies like the FDA routinely take measures to improve quality and safety. Correspondingly, executives are in constant pursuit of better ways for utilizing key resources to stay ahead of regulations and deliver high quality products. In the pharmaceutical industry, automated Corrective and Preventive Actions (CAPA) and deviations management have traditionally played a central role in improving the quality of products and processes and ensuring compliance. However, from our research, experiences, and discussions with leading industry executives, it’s apparent that there are a number of additional automated Enterprise Quality Management Software (EQMS) functionalities organizations are using for this.

Below, with the use of benchmark data, I’ll discuss executive focus areas and also which technologies and functionalities companies are using to ensure compliance and improve quality.

Top Quality Management Objectives of Pharmaceutical Executives

The LNS Research 2012-2013 Quality Management Survey helps to visualize this point. One question asked which quality management initiative executives were most focused on in 2012. As seen in the chart below, when compared to all industries as well as the life sciences industry, the pharmaceutical industry has two standout points.

Reducing non-conformances in manufacturing is the top objective for many pharmaceutical companies with 36% of respondents choosing this. The second most frequent objective is ensuring compliance, which is related to non-conformance reduction and was selected by 27% of executives. This isn’t surprising given the regulatory environment in the pharmaceutical industry but one surprise that did stand out was how few pharmaceutical companies are focused on reducing the cost of quality in comparison to aggregate (38% vs. 9%).

top quality objectives
top quality objectives

The Adoption of EQMS Functionalities

A separate question of note in the survey regards which EQMS functionalities organizations were using in 2012. As shown in the graph below, a vast majority, more than 70%, in pharmaceuticals were leveraging CAPA. This functionality directly relates to the top two quality objectives, ensure compliance and reduce non-conformances. What should be noted however is how quickly the adoption of other types of automated EQMS falls off in the industry. For many pharmaceutical companies, the NC/CAPA process was automated with EQMS but additional processes were never included, meaning they are still disconnected and managed by disparate or paper-based systems outside of EQMS.

eqms functionality
eqms functionality

What’s interesting, though, is how effective adding these additional functionalities is at ensuring compliance and reducing non-conformances. We asked a performance question regarding the percentage of products produced in compliance. When we analyze this compliance performance against automated EQMS functionality adoption, a few interesting points emerge around which functionalities are most impactful for helping to ensure compliance.

eqms impact
eqms impact

The results are surprising, with four functionalities standing out in the above boxplot: change management, audit management, Failure Mode and Effects Analysis (FMEA), and Hazard Analysis and Critical Control Points (HACCP). For the companies having adopted these functionalities, the upper two quartiles (top 50%) of organizations using these functionalities are experiencing 99% to 100% of products in compliance, which is very strong performance when compared to some of the other functionalities. Second, and even more impressive, is the performance of the two lower quartiles (bottom 50%) which are achieving strong performance in their own right, 98% - 96%. When compared to some of the other types of functionality that have very little impact on performance, the bottom 50% of performers can range from 98% all the way down to 90% or lower.

Clearly, leading pharmaceutical companies have already invested in EQMS with NC/CAPA, but many have not taken it far enough. To best address the pressures of the industry today, it is imperative for leaders to take full advantage of EQMS as a business process platform and build out a full portfolio of important quality management processes. By mapping and connecting processes across the value chain, companies can pursue the task of ensuring compliance and reducing nonconformances in manufacturing in a strategic way. With EQMS, business processes can be built out in a manner that provides cross-functional communication and collaboration that would otherwise be very difficult to achieve.

About the Author: Matthew Littlefield founded LNS Research in August of 2011 and is now President and Principal Analyst. Matthew is a recognized industry expert and contributes to many leading industry publications. When he isn’t writing, Matthew is a frequent public speaker on manufacturing initiatives, drawing upon his industry analyst, engineering and shop-floor management experience.  URL:

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