To be effective, CAPA issues management must comply with current FDA regulations and ISO quality standards. Part of this involves tracking and recording customer complaints and CAPA processes using corrective action software.
Select all the resources you’re interested in downloading
Corrective and preventive actions are extensively used to improve the quality of products, processes, and the overall health of the business. A well placed CAPA program within the quality management system ensures that the business is managed with optimized efficiency. It is important to address the issues that are raised through various sources as they present several kinds of risks and threats to the business. CAPA issues management is a concept widely incorporated in quality management systems to ensure that issues affecting the business are properly managed, monitored, and mitigated. Paper-based and hybrid systems lack the necessary tools to provide a closed loop corrective and preventive action tracking system which is the reason companies are now migrating towards CAPA issues management web-based solutions that help resolve CAPA issues in real time. MasterControl provides CAPA issues management software that automates and streamlines the entire CAPA process.
The basis of corrective action issues management is focused on properly documenting the issues which lead to the identification of the root causes behind each issue. MasterControl corrective action preventive action issues management solutions are entirely web-based, providing an online platform for authenticated users to log in and document all aspects of the issues. This leads to the development of a comprehensive knowledge bank that captures and logs the root causes behind the issues. This is a vital component of issues management, since the identification of root causes is a major breakthrough in resolving issues. Higher level management is then able to plan and implement corrective and preventive actions across the enterprise.
MasterControl software eliminates redundant data entry operations and prevents any information from falling through the cracks by automating the CAPA forms. The quick search and retrieval of documents also helps users collaborate and work toward finding the best possible fixes for the issues.
The MasterControl CAPA issues management system provides a time-tested issues management solution as part of an integrated quality management software system. Hundreds of regulated companies around the world trust MasterControl's approach to issues management.Modern trends in business emphasize the importance of adhering to FDA and ISO regulatory standards. It is not only important to attain but also sustain compliance which is why MasterControl CAPA issue management helps companies achieve a state of continual compliance. This ultimately leads to the development of FDA and ISO approved business practices, which helps businesses maintain long term compliance.
MasterControl software boasts state-of-the-art compliance management that reduces the lifecycle from submission to resolution. MasterControl's three-stage approach to issues management begins with a pre-configured form that processes customer complaints, automatically transfers them to internal investigation, and culminates with the resolution of the process for Issues Management. As an additional bonus, the advanced analytics and reporting features allow users to generate several types of reports that accurately reflect the true position of issues management within the company. For detailed real-time visibility, reports can be automated on a recurring schedule. Management is able to base important decisions that affect the company's future on basis of these valuable reports.
Because it's fully integrated with other quality-related processes such as audits, nonconformance, customer complaints, change management, etc., the system can effectively manage issue resolution no matter where an issue originates or how many departments the problem touches.
MasterControl CAPA interconnects different quality subsystems to track and correct incidents before they escalate into serious problems. The application for CAPA includes an "8D" process to guide the quality team through every step of CAPA implementation. The integration with other quality related-processes (i.e., audits, nonconformance, customer complaints, change management, etc.) serves as a pivot point for management to effectively resolve issues within an acceptable timeframe. As soon as an issue originates, it is easily located and tracked within the system, allowing for effective data gathering through multiple business areas and departments. Ultimately, an issue captured from any source is efficiently detected and resolved through the MasterControl corrective issues management software demonstrates the vitality of a healthy and compliant quality management system.
To learn more about CAPA issues management, CAPA, and the MasterControl solution, please feel free to contact a MasterControl representative.