Corrective Action Preventive Action (CAPA) Report

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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Product Information

Discover how MasterControl CAPA Software can manage your Corrective Action Preventive Action process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • Avoid 'death by CAPA' and learn about how MasterControl CAPA software automates, streamlines and manages not only all CAPA-related documentation and activities, but also the documents and tasks of other quality processes.
  • To effectively deal with quality events you need two things: efficient QEM processes and well-trained personnel. At the end of your two-day MasterControl QE Audit, you will have learned how to achieve both.
Product Data Sheets
Q&A's
  • Learn from QMS/CAPA guru Ken Peterson about how good event management is essential to a reliable QMS that can withstand the toughest regulatory scrutiny.

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your CAPA program

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
Toolkits
  • Tailored specifically for Quality Managers. Find out how closed-loop quality management can help you connect people, processes, and data across the value chain. Includes: 4 webinars, 3 white papers and much more.

Educational Materials

Get insider information about the most relevant issues in CAPA Reporting today, and how to navigate and overcome the complexities of FDA Regulations.

Product Data Sheets
White Papers
  • Medical device manufacturers are seeing increased warning letters, resulting in supply chain delays and even plant closures. CAPA guru Ken Peterson shows you how to kick-start your CAPA process and keep the FDA off the radar screen.
  • Learn how to identify, correct and prevent problems that plague weak CAPA systems as well a seven distinct procedures that can insure compliance with FDA and ISO requirements.
  • Learn why the FDA, ISO and other regulatory agencies place so much emphasis on CAPA and closely scrutinize the amount of open CAPAs an organization has. Also examine the pros and pitfalls of three different approaches to CAPA management.
Product Data Sheets
Webinars
  • Learn the number one item cited by the FDA in 483s and warning letters. And why poor investigation techniques only identify superficial symptoms rather than root cases.


Role of Corrective Action Preventive Action Reports in the Quality Management System


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.


Corrective Action Preventive Action (CAPA) Reports Made Simple with MasterControl


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.

certain level of product quality.


MasterControl Corrective Action Preventive Action (CAPA) Reports Provide Valuable Insight


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.

For More Information on Corrective Action Preventive Action (CAPA) Reports


To learn more about a CAPA reports, please feel free to contact a MasterControl representative.

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