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by Valarie King-Bailey

Nearly every aspect of business operations has an effect on quality. Despite this fact, many organizations aren’t leveraging today’s technology to address this fundamental quality mandate. Corrective and preventive action management is a daunting process that most organizations struggle to handle manually; economies of scale in many organizations highlight the limitations of this approach. In contrast, effective management of the CAPA process not only ensures product quality but also makes good business sense for organizations that choose to adopt an automated approach.

As more organizations embrace CAPA management as an essential quality process, it’s important for them to carefully evaluate the requirements of an effective CAPA system and determine the most effective and practical approaches to addressing those requirements. To achieve the greatest return on technology investment, companies need to adopt a top-down enterprise approach to CAPA management.

Foundation for effective CAPA management

The heart of an effective CAPA program is consistency. Consistency ensures quality. Developing an effective CAPA management program requires a shift in thinking, from a bottom-up to a top-down approach to system implementation. Many organizations today implement CAPA management solutions as bottom-up “point” solutions that are implemented departmentally to serve the needs of specific user groups.

Bottom-up point solution implementations have limited effectiveness in achieving operational efficiency and addressing systemic quality problems because they lack broad enterprise reach. These compartmentalized solutions can actually contribute to a decrease in operational efficiency--and even threaten quality goals--if systems lack compatibility or require customization to achieve compatibility with the enterprise.

The nature of effective quality management involves identifying root causes of problems or taking proactive steps to prevent quality problems before they occur. This requires integration of front-end and back-end systems such as enterprise resource planning, document management and CAPA applications across departmental business processes. These systems extend across the enterprise to identify, detect and correct quality problems within the organization in a closed-loop fashion. This approach avoids disconnects that lead to inherent quality problems that go largely undetected in most organizations. Establishing an effective, fully integrated quality management system can be somewhat complex, depending on the organization, but the advanced CAPA systems available today make this achievable.

Many CAPA packages are database-oriented in their design and architecture, enabling organizations to enter and manage an event through a workflow process. These packages also include support for the latest regulatory guidelines, such as ISO standards or the Food and Drug Administration’s 21 CFR Part 11 guideline on electronic signatures. Unfortunately, these systems lack integration with other key business processes, which limits their overall effectiveness in addressing real quality problems.

Utilizing a CAPA package has some merit in small organizations with perhaps a single geographic location and centralized operations. However, in most midsized and larger organizations, CAPA events cover a broad spectrum of issues and can affect many departments and divisions. Almost anyone in an organization can either raise a corrective action event or be a participant in a corrective action process at any time. This alone requires rethinking the “point solutions” approach to automating the corrective actions process.

CAPA management is a collaborative process requiring interaction and input across various parts of the organization. Enterprise access is key to ensuring successful deployment of a CAPA management system.

Enterprise compliance management

Enterprise compliance management represents a holistic approach to regulatory compliance. Collaboration and consistency are the keys to achieving compliance and reducing associated risks. When applied across multiple lines of business, enterprise compliance management systems, such as CAPA, ensure that regulatory applications are deployed in a cohesive and integrated manner. Effective management of CAPA requires this kind of comprehensive strategy.

Most organizations already employ a document management system for their quality documentation. Throughout a typical CAPA investigation, these documents are often accessed for reference. However, because CAPA and document management systems are often disparate and nonintegrated, error-prone hybrid (e.g. manual/electronic) processes are developed that can lead to additional problems.

A good CAPA program should integrate traditional document management, ERP and other process technologies seamlessly, enabling ready access to quality documentation throughout the corrective action process. This approach assumes a fully electronic workflow across the organization, utilizing 21 CFR Part 11-compliant electronic signatures, when appropriate.

In the past, the vision of enterprise compliance management escaped many organizations. Customization was considered the most effective way to address requirements over the long term. In hindsight, however, the drive for customization led to extensive system implementations that largely failed, costing organizations millions of dollars in development, validation and implementation. Organizations are now looking to the vendor community for off-the-shelf applications that can be readily deployed across the enterprise and are easy to integrate without expensive customization. This is the essence of enterprise compliance management systems today.

Essential elements for enterprise CAPA management

The primary issue with CAPA management is that corrective actions often aren’t properly followed through, documented and closed in a timely manner. This can lead to further product quality problems and regulatory fines.

A CAPA management system must include the following key elements:

Enterprise access and collaboration

Consistency

Closed-loop corrective action plan process (providing perpetual “triggers” and reminders to close the loop)

Compliance with current regulations

Integrated solution (vs. “point”solution) should seamlessly integrate document management, ERP, records management, event management, workflow, task management, records management and project management.

Comprehensive statistical analysis

Flexible, task-oriented workflows

Easy validation

Enterprise collaboration is an essential requirement for a good CAPA program. As employees execute tasks in a corrective action plan, they exchange information, ideas and data in a collaborative manner. This collaboration should be seamlessly integrated into the way they do business. Many people use e-mail for ad hoc collaboration and correspondence on quality issues. E-mail is easy to use and readily accessible across the enterprise, which is why it’s the communication medium of choice in so many organizations. Most employees have e-mail, yet e-mail isn’t always a secure, validate-able medium. A CAPA system must be as easy to use as e-mail and provide a higher level of security and auditing, in compliance with regulatory requirements. To ensure successful user adoption of a CAPA system, it must be easy to use, deployed enterprisewide and integrated into normal business processes.

Effective records management is essential to any enterprise compliance management system, including CAPA. CAPA systems are inherently data-oriented, as opposed to document-oriented. Therefore, as CAPA events are documented and closed within the system, they become official records and require the same level of regulatory control as all cGxP records governed by 21 CFR Part 210 and 211. Thus, effective management of electronic records requires a comprehensive records management system.

Many CAPA management system developers don’t realize the legal consequences faced by their customers for ineffective management of electronic records. Their CAPA system offerings ignore the critical records-management component altogether. For example, in the heavily regulated life sciences industry, organizations can generate terabytes of electronic records, but lack the ability to ensure their integrity and authenticity as records migrate over time. An effective CAPA system should include a foundation of a good records management strategy.

An efficient CAPA system should help organizations avoid manual processes and unnecessary data entry. This facilitates the successful execution, documentation and closure of corrective action plans.

Return on investment

Regulatory compliance is no longer considered a “necessary evil.” Many companies are finding that, if implemented properly, a successful CAPA management system makes good business sense and can yield bottom-line results. As stressed throughout this article, a good CAPA system requires an integrated approach.

A well-chosen CAPA management system can deliver a significant return on an organization’s technology investment, realized by leveraging existing technology that extend CAPA management capabilities across the enterprise. Recent case studies suggest that the return on investment can be as high as 300 percent over a two-year implementation period. In many cases, well-chosen CAPA management systems are paying for themselves in fewer than six months.

Integrating processes and procedures across the organization yields benefits far beyond the CAPA process. World-class organizations are beginning to understand the long-term value of enterprise compliance management and are adopting CAPA systems that extend across their enterprises. These changes will ultimately improve overall product quality and safety, and affect our lives for years to come.

About the author

Valarie King-Bailey is chief marketing officer for QUMAS, an Enterprise Compliance Management Systems vendor. She is a frequent speaker on compliance issues. Letters to the editor regarding this article can be sent to letters@qualitydigest.com.