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5 CAPA Best Practices for Life Sciences Manufacturers

Pharma manufacturing professional following CAPA best practice.

In manufacturing environments, something will inevitably go wrong that affects product quality. No matter how large or small the issue may be, there’s no such thing as perfect production. That’s why regulators require pharmaceutical, medical device, and other life sciences companies to appropriately manage and document their corrective action/preventive action (CAPA) efforts. But even more important than the fact that they’re required by regulators, CAPA management processes have a direct and measurable impact on a company’s ability to improve product quality.

What Does Effective CAPA Management Entail?

Your corrective action process should account for all the possible sources of a quality issue and provide a feedback mechanism to prevent it from recurring. An effective preventive action process should minimize the number of quality deviations that occur in the first place. These two processes functioning in concert should measurably reduce product scrap, returns, recalls, and warranty claims.

When quality problems arise, life sciences manufacturers must resolve them in timely, effective, and compliant ways that are suited to the specific issue. If the problem is minor and there’s a solution that can be performed immediately and sufficiently, then the quality event can be closed with an effective containment or correction. If the issue is more significant, it should be escalated to a CAPA. For CAPA management processes to be comprehensive and effectual – and for quality improvement to be continuous – they must be fully incorporated into the overall quality management system (QMS).

5 CAPA Best Practices for a Holistic Approach to Quality

If you’re aiming to optimize and simplify CAPA management in your organization, the following CAPA best practices offer a good starting point that can be adapted to suit your company’s unique needs. These tried-and-true CAPA strategies provide a roadmap for simplifying compliance and can also help you get your products to market faster.

#1 Formalize Your QMS With CAPA Playing a Central Role

While in the process of implementing a formal QMS, CAPA management processes should be incorporated from square one. With all the many people, activities, documents, and data inputs involved in CAPA management, it’s imperative to have a centralized means of doing it efficiently and effectively. The most reliable way to ensure that CAPA management is fully integrated into your QMS is to implement a proven CAPA software solution. A closed-loop solution will automate CAPA processes and allow you to make timely decisions and long-lasting quality improvements faster. CAPA software also automatically maintains complete, traceable, and compliant audit trails for compliance purposes.

#2 Integrate Training With CAPA Management

When a CAPA results in a change to a standard operating procedure (SOP) or work instruction, it’s imperative that all personnel get up to speed quickly so problems can be corrected or prevented from happening in the future. To make certain this happens in a timely and compliant manner, the appropriate personnel must be adequately trained. If you have CAPA software that integrates training with CAPA management, everything you need for employee training is readily available from a single source and the routing of training tasks can be automated.

#3 Integrate CAPA With Risk Management

Some companies have risk management processes but not a formal CAPA management process. Conversely, other companies may have good CAPA management processes in place but don’t have well-established risk management processes. When one of these complementary processes is missing or not optimized, the organization’s approach to quality is disjointed and full of gaps. Connecting these processes via robust CAPA software provides a consistent means to assess the potential impact of problems and the actual risks to the company and/or its customers.

#4 Identify Deviations Requiring CAPAs and Base Actions on Their Characteristics

Not every quality issue requires a CAPA. Determining which type of action is needed – corrective, preventive, or no action – should be based on the specific characteristics of the event, i.e., its risk, impact, severity, and frequency. Truly intelligent CAPA software solutions provide workflows that simplify these determinations and guide users through the entire CAPA process, from root cause investigation through the implementation of corrective actions.

#5 Enhance CAPA Management Transparency to Improve Audit Readiness

All of the quality documentation a life sciences company generates must be made available during audits and regulatory inspections. If your organization is still using paper documents and manual processes, you know all too well that paper can often be hard to track down or easily misplaced. If you can’t deliver the information an auditor wants when they want it, you run the risk of noncompliance. With a CAPA software system, you can give auditors easy, quick access to vital documents and complete data. An automated and integrated QMS provides you with a single centralized repository for all CAPA records and other essential documentation.

Learn More About CAPA Best Practices

CAPA management is an evolving process that you can always improve upon. For more CAPA management tips, visit MasterControl’s CAPA software page.


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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