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Corrective Actions - CAPA Software Systems

MasterControl's CAPA Systems are designed by industry practitioners for automating the Corrective and Preventive Action (CAPA) process in any organization. A CAPA software 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 decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

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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.

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.

How can CAPA Software Systems from MasterControl Benefit You?

MasterControl's Corrective Action software is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other quality processes critical to regulatory compliance, such as change control, audit, and customer complaints. Here's how the CAPA systems from MasterControl addresses some of the major challenges that companies face in establishing and maintaining effective corrective action and preventive action processes:

CAPA Software Process Diagram

Corrective Action Preventive Action CAPA Management Challenges

MasterControl CAPA Software System

Inefficient CAPA System for Corrective Action

Paper-based and hybrid systems for Corrective Action and Preventive Action are inexpensive initially. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.

Efficient System for Corrective Action

The MasterControl Corrective Action system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire CAPA process, from initiation to investigation and all the way through closure. Provides a secure, centralized, and Web-based repository for all CAPA documents.

Disconnected CAPA System Processes

A CAPA may be triggered by Form 483 findings, ISO quality audits, customer complaints, or some other source. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable.

Connected CAPA Software Systems

The MasterControl Corrective Action software integrates the corrective action and preventive action processes with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.

Poor CAPA Reporting

When customer complaints, deviations, adverse events, and other incidents that can trigger a Corrective Action and Preventive Action are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports. A hybrid system requires re-entering data from hard copy into an electronic system, a process prone to delay and mistakes.

Efficient CAPA Reporting Software System

With the MasterControl CAPA software, a CAPA form can be launched directly from another form (i.e., customer complaint, etc.) to streamline the CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA.

Lack of CAPA Oversight

Poor implementation of CAPA systems a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.

Increased Oversight with CAPA Software

The MasterControl Corrective Action software tracks quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. The system provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the CAPA process and can be more proactive about improving their quality system.

CAPA Software Systems Features

Here's a summary of the MasterControl Corrective Action (CAPA) software system and its powerful features:

Best-Practice Forms: MasterControl's Corrective Action System provides best-practice electronic forms and workflow routes that can be used as is or customized based on a company's needs. The CAPA software solution includes:

  • An "8D" process to guide the quality team through every step of Corrective Action and Preventive Action (CAPA) implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence.
  • A Corrective Action and Preventive Action (CAPA) form that can be configured to show the initiator only the relevant information to this step and to require completion only of fields related to data entry.

Connected Quality Processes: MasterControl CAPA software is designed as a "closed loop" solution, streamlining processes, interconnecting different quality subsystems, and tracking quality incidents that can escalate into a CAPA. For example:

  • A Corrective Action and Preventive Action (CAPA) form can be launched directly from another form (i.e., customer complaint, audit findings, etc.) to streamline the CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
  • Relevant data from a form that could potentially require a corrective action is automatically entered into a CAPA form, reducing data entry and eliminating errors from manually transferring information.
  • Through the Internet, customers, vendors, and others outside the company can submit a form, such as customer complaint or product issue report, that could lead to a CAPA. Off-site and traveling users can also complete forms pertaining to the Corrective Action and Preventive Action (CAPA) process without being connected to the MasterControl system. They can complete forms offline and then upload.
  • MasterControl CAPA software can be integrated with the training application for a more efficient system. A CAPA that causes a change in product design or function will invoke training tasks upon approval of the change. MasterControl CAPA software can automate distribution and grading of online exams, which can be used as proof of personnel competency during FDA inspections or ISO audits

Advanced Analytics and Reporting: With MasterControl, CAPA coordinators can monitor the entire quality management lifecycle, from input to closure. They will get a complete picture of the quality system with the help of the following reporting capabilities:

  • Ability to dynamically capture, trend, and link data needed to solve problems, improve processes, and implement preventive measures. A variety of reports (issue summary, aging/overdue, cycle time, etc.) come standard. You can customize reports for issue review, problem prevention, etc.
  • Data can be grouped together by a date interval and then charted over a date range. For example, the number of customer complaints can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so that Corrective Action and Preventive Actions can be reported by product, department, and root cause.