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CAPA Overload and Other Perils to Avoid on Your Compliance Journey

There are countless obstacles to compliance that arise as a pharmaceutical company undertakes its regulatory journey. Data control failures. Delays in getting signature approvals. Training oversights that lead to unforeseen quality events. The list seems endless.

One particular hazard poses a significant challenge to pharma companies that are striving to maintain compliance and get high-quality products to market quickly: corrective action/preventive action (CAPA) overload. Too many pharma companies get bogged down with disorganized and time-consuming investigations into the causes of quality events like deviations and nonconformances. “Death by CAPA” is a common problem companies bring upon themselves when they push nearly every quality issue through a CAPA process rather than taking a more strategic approach.

Developing a Smarter Pharma CAPA Management System 

Although every pharma company has to have some form of CAPA management system in place, it’s not uncommon for organizations to take an ad hoc approach to every quality event, handling each one on a case-by-case basis. Without a formal, systematized strategy to manage CAPA in pharma environments, however, there is needless waste of time, effort, and resources. A makeshift, disorganized CAPA management system inevitably leads to delays and greater difficulty in achieving and maintaining compliance.

Innovative CAPA management system solutions are helping pharma companies overcome these challenges and enabling them to manage CAPA processes more efficiently and effectively. With a formal, risk-based CAPA process reinforced by purpose-built quality management software, pharma companies can establish what McKinsey & Company life sciences experts are calling a “smart quality” approach. This modern, smarter approach is resulting in dramatic improvements to quality assurance processes in real-world use cases.

When innovative technologies and smart quality principles were jointly implemented at several life sciences companies, McKinsey researchers reported that the organizations augmented their ability to identify, explain, and eliminate the root causes of recurring deviations and nonconformances, which led to as much as a 65% reduction in the overall volume of issues. 1

Many companies are even incorporating AI-driven applications into their CAPA management systems. Some of these innovative AI-powered solutions feature predictive analytics capabilities that enable organizations to leverage previously inaccessible quality event data to streamline quality processes and make faster and more proactive decisions. McKinsey’s case studies showed that the predictive capabilities of solutions that incorporate advanced analytics are revolutionizing the way CAPA investigations can be conducted. The companies they tracked had advanced systems that greatly enhanced the organizations’ ability to predict the most likely root causes and their underlying drivers. The subsequent improvements enabled the companies to reduce investigation cycle times for deviations and nonconformances by 90%.

The combination of modern CAPA management systems and smart strategies is the key to eliminating CAPA overload in the modern pharma industry. You won’t have to endure CAPA bottlenecks or costly production and compliance delays if your organization has a formalized and digitized CAPA management system that automates the routing and approval of CAPA-related documentation and includes configurable CAPA workflows and forms.

Take the Next Step on Your Pharma Compliance Journey

Streamlining your CAPA management system is just one way to make your compliance journey smoother. To learn more about avoiding CAPA overload and other similarly challenging compliance hazards, take this interactive regulatory road trip.

  1. Making quality assurance smart,” by Tacy Foster, Evgeniya Makarova, and Vanya Telpis, McKinsey & Company Life Sciences Insights, Jan. 29, 2021.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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