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Corrective Action Preventive Action (CAPA) Form

MasterControl's CAPA Software Systems are designed by industry practitioner for automating the CAPA process in any organization. A Corrective Action Preventive Action system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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Educational Materials

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

Product Data Sheets
White Papers
  • 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.
  • 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.
Product Data Sheets
  • 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.

Product Information

Discover how MasterControl CAPA Software can manage your CAPA 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.
  • In this FDA-approved workshop you will learn root cause analysis (RCA), risk based issue review and quality event management (QEM) methodologies, which are critical when implementing CAPAs.
Product Data Sheets
  • 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
  • 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.

Using the Corrective Action Preventive Action Form

Electronic CAPA forms are just one of the valuable offerings available as part of the MasterControl suite's configurable applications. MasterControl CAPA helps regulated companies efficiently manage the entire corrective action process. MasterControl CAPA is an online system for storing and resolving quality issues and complaints that are generated from various sources. Since a company's business can be intricate, the remedies that help in fix the issues must be equally elaborate. This calls for thorough documentation of each stage of a CAPA, which is why it is important for users to have the ability to collaborate on the best possible solutions for resolving issues. MasterControl CAPA forms automate tasks such as routing, notification, follow-up, escalation, and approval with a simplified, integrated approach.

The Corrective Action Preventive Action Form follows best practice guidelines and can be customized to fit the unique needs of each company and each industry. This form increases efficiency by only showing the user the information / tasks they need to provide / complete. A CAPA form can be initiated through different sources such as customer complaints, staff observation, internal quality audits, management review, service request, etc. The main objective of raising a CAPA is to resolve an issue, which is why it is important to properly document as a quality event. Managers can use MasterControl's CAPA forms for recording CAPAs so that all relevant information is properly entered for issue resolution. Forms used in paper-based or hybrid CAPA systems may allow users to enter issues but it is likely that with repeated data entry some of the relevant information may fall through cracks or be subject to human error. To avoid such complications, MasterControl CAPA forms provide seamless, automated data entry, which allows all the information pertaining to an issue to be stored without any data slippage or data repetition.

MasterControl corrective action forms allow the version of documents in the system to be controlled so that only the latest version of any CAPA document is available to authorized users. Added benefits to users include rapid document search and retrieval, along with a feature that allows CAPA documentation to be prepared offline and then synced with the online content as soon as the user logs onto the portal.

MasterControl's Corrective Action Preventive Action Forms are Compliant

CAPA forms are usually distributed into two sections: corrective and preventive actions. MasterControl's corrective action form allows management to observe the issue, analyze the possible risks associated with the problem, and formulate a remedial action for resolving the issue. The advanced analytics built into the software help in observing the data and deducing the risks that are a potential threat to the company's business. On basis of the analysis, higher-level management can better decide on possible solutions for resolving the issue.

MasterControl corrective action and preventive action forms help management alter existing procedural methods to eliminate the occurrence of errors. This is an important step in elaborating the steps that must be taken to change standard operating procedures in order to eliminate recurring issues. MasterControl CAPA forms provide preventive actions that can be published at the enterprise level so that users have the assurance that they are only working with the latest set of procedures.

Therefore, MasterControl CAPA forms provide the mechanism for resolving and preventing issues that are raised from various sources so that the company's business can avoid risk and maintain compliance.