A CAPA report is a mechanism for correcting and recording defects and nonconformances. Learn about how the robust reporting functionality of MasterControl CAPA can streamline CAPA processes, including the completion of the corrective action reports.
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Technological trends are evolving rapidly and so are the demands of customers. Companies are now employing complex strategies and concepts in their business paradigm to suffice these requirements. As a consequence to this, the processes residing within the system have become intricate in nature. It is becomingly increasingly difficult to manage the array of quality processes within the business. Issues that are raised through different sources including customer complaints, quality control, audits, service requests, etc are necessary to ensure product quality. A compliant quality management system helps the management team to identify the issues for which automated corrective and preventive actions are implemented. It is important to monitor the progress of the CAPA program residing in the business. Usually, reports are generated to verify and ensure proper implementation of CAPAs and their application at the enterprise level. MasterControl corrective action preventive action reports help companies in observing various aspects of the CAPA program to maintain a certain level of product quality.
A well organized CAPA program within the quality management system (QMS) allows management to identify, track, correct and prevent recurrence of issues. Executing a product's complete lifecycle requires close monitoring of all processes, people, resources etc. Each activity requires careful planning and allotment of resources. Management teams rely on smooth culmination of processes so that the product is safe, cost effective and compliant. The MasterControl CAPA solution helps companies resolve bugs, errors, anomalies and issues pertaining to the product. It is an essential component in any company's QMS to maintain quality as well as raise the existing quality standards for the product. Paper-based or hybrid CAPA systems may be cost-effective but eventually these systems are inefficient; requiring extensive man-hours and resources for issue resolution.
MasterControl corrective action preventive action reports are an important constituent of the MasterControl CAPA software. Each stage within the MasterControl CAPA software is tracked which helps the users trace the steps applied in resolving the issue. The management team can generate reports for all the activities associated with corrective action (routing, notification, escalation, and approvals) that are all executed electronically. The entire process for the corrective action preventive action report is automated by MasterControl, beginning with the instigation of the CAPA and initiating the corrective action, and concluding with the resolution of the CAPA.
MasterControl corrective action reports provide advanced analytics and reporting capabilities which helps the management team to be better informed to make better business decisions. Any change or update made to a standard operating procedure is electronically approved and published on the web-based platform. The software allows stakeholders to be informed about the issues and collaborate in deciding upon the corrective action to take against the issue. This business practice helps in bringing various solutions on the forefront and selecting the one that best fits the business requirements. The advanced analytics helps in conducting a thorough investigation and deducing the root cause of issues. Data entry is automated through customizable forms which help in preventing leakage or slippage of any information.
Our corrective action preventive action reports are compliant with the FDA, GxP, ISO and other global regulations. Our reports also provide a comprehensive and broad outlook into all aspects of the company's core business. This allows the management team to attain and sustain compliance by adhering to the documented standard operating procedures. Any deviance is immediately reported and a a CAPA, if warranted, can be automatically launched. This mechanism leaves very little room for non-conformances. Corrective action preventive reports generation can be automated on a schedule so that reports are received by respective stakeholders on the specified date and time. The top level business executives examine these reports to make several important decisions that affect the company.
To learn more about a CAPA reports, please feel free to contact a MasterControl representative.