|A poorly maintained paper-based CAPA
process may contribute to FDA violations.
In a regulated environment, CAPA is a requirement for addressing and mitigating deviations and nonconformances. A quick review of FDA warning letters indicates it’s a dreaded four-letter word for many companies cited for violations.
Some organizations think of CAPA only after quality issues have emerged. Others have CAPA systems in place but they are inadequate. This is evident in the case of a medical device firm, which received an FDA warning letter. Among other things, the agency said, “your CAPA implementation is inadequate in that you do not trend component failures” (1).
In some cases, a poorly maintained paper-based CAPA process contributed to FDA violations. For example, the FDA cited a pharmaceutical manufacturing company for different instances of failure in data integrity, including using “scratch paper” for documenting CGMP-related data. “The data on these scratch paper records did not always match the data on corresponding official batch records,” according to the warning letter (2).
How does your organization handle CAPA? In our experience at MasterControl, companies follow an evolutionary path, usually starting with a paper-based process, then moving to part-electronic and part-paper system (hybrid) before finally switching to an electronic system.
Let’s examine the common pitfalls of each type of system.
Paper-Based System: Using paper is cheaper compared to other systems. You can customize it to meet your unique requirements. However, it also has many pitfalls: extensive follow-up by phone and email to make sure CAPA tasks are completed; forms filled in manually might be inaccurate or incomplete; reporting can be problematic because data is not readily available; and it’s almost impossible to see where the bottlenecks are if you’re buried in paperwork.
Hybrid System: This is more efficient than a paper-based system because it usually includes electronic tracking and reporting, such as a simple spreadsheet that tracks some subset of the data on the form, or a database application that allows electronic entry of CAPA data. Just like a paper-based system, however, it requires manual distribution, follow up, and escalation of tasks.
Electronic Solution: Companies either build a custom application, or more commonly, purchase a package from a software vendor. An electronic solution can overcome most of the challenges discussed above. If you’re considering buying a CAPA software solution, here are some of the basic features you should be looking for:
- Automated Distribution, Follow up, and Escalation of Tasks: The system should automate all CAPA-related documents and tasks, including routing, follow-up, escalation, and approval. This will greatly improve efficiency and also facilitate buy-in and accountability for individual employees involved in the process. Management will be able to see where the bottlenecks are in the process because they will have access to real-time data.
- Web-based System: Look for a web-based solution so employees from all site locations can access and use the same data repository. Departmental CAPA solutions that are not Internet-based keep quality data in a silo that make it difficult to identify systemic problems.
- Built-in Reporting and Analytics: The system should have robust reporting and analytic capabilities. It should give you the capability to report on each data field tracked by the system. Online charting should be available to enable users to easily trend quality data.
- Audit Trail and Electronic Signatures: The system should have a secure, time-stamped audit trail of all changes made to any record. This information should be automatically captured and secured. Look for a system with e-signature capabilities. Electronic manifestations should be automatically appended to each document including the printed name, date, time, and meaning of the electronic signature.
Regulated companies are required to incorporate CAPA in their quality systems, but most of them use inadequate tools. Automating a paper-based or hybrid system is an essential first step toward improving the CAPA process for a better, safer, and competitive product in the marketplace. In searching for the right solution, make sure you leverage the latest technology to increase efficiency, save time and money, and strengthen your regulatory compliance.
This article is based on a white paper, “Does Your CAPA System Need a CAPA? Automating Corrective and Preventive Actions in the FDA Environment.” If you’re interested in reading more about the pros and cons of different types of CAPA systems and how you can improve your existing processes, download the complimentary white paper below.
Cindy Fazzi is the editor of MasterControl Insider, a monthly publication for MasterControl users. She writes about the life science industry and other regulated environments. Her two decades of experience as a news reporter, writer, and editor includes working for the Associated Press in Ohio and New York. She has a master’s degree in journalism from Ohio State University.
(2) FDA warning letter issued to Marck Biosciences Ltd., viewed on Jan. 5, 2015 at: