CAPA Software

Get the best CAPA software for your business. Compare product reviews, pricing below. Read our buyer’s guide for more help.

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MasterControl Qx Screenshot
MasterControl Qx
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MasterControl’s software platform improves quality management processes through employee training management, document and change control, risk assessment, audits and preventative action, and more. Control quality throughout…
Client OS
Web
Deployment
Cloud Hosted
AssurX Screenshot
AssurX
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(3)
AssurX is a cloud-based quality management software solution that allows you to manage and automate quality and compliance processes from one system. AssurX is designed for regulated industries including manufacturing, life…
Client OS
Web
Deployment
Cloud Hosted
TrackWise Screenshot
TrackWise software by Sparta Systems is an enterprise quality management solution (EQMS) that optimizes quality, ensures compliance, reduces risk, and lowers costs for world-class clients across a range of industries…
ComplianceQuest Screenshot
ComplianceQuest
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(1)
ComplianceQuest is an enterprise quality management system (EQMS) that is cloud-based and easily configurable to meet your needs. This solution is built on Salesforce.com to provide you with a reliable, user-friendly, and…
Price Range
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Starting Price
$20/month/user
Client OS
Web
Deployment
Cloud Hosted
HQMS Screenshot
Harrington QMS (HQMS) is an enterprise quality management system that helps improve quality processes and maintain regulatory compliance. HQMS can be integrated with ERP systems like Oracle and SAP, as well as security…
Client OS
Web
Deployment
Cloud Hosted
Infor Fourth Shift Screenshot
Infor Fourth Shift
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(3)
Infor Fourth Shift ERP is designed to assist manufactures to improve your operational quality, speed, become more effective in order to achieve improved bottom line results. Infor Fourth Shift ERP helps you achieve faster ROI…
Client OS
Windows
Deployment
On-Premises
IQS Screenshot
IQS
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For more than 25 years, IQS has been delivering market-leading quality management and compliance solutions. The addition of our Software as a Service (SaaS) web delivery model has helped us stay on the leading edge of what…
Client OS
Windows
Deployment
Cloud Hosted
SmartSolve Screenshot
SmartSolve from Pilgrim Quality Solutions is an enterprise quality management software solution that helps businesses manage quality processes, risk management, and regulatory compliance. SmartSolve can integrate with other…
Client OS
Web
Deployment
Cloud Hosted
Qualityze Screenshot
Qualityze
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(1)
Qualityze is a cloud-based technology solution provider for Enterprise Quality Management System (QMS). Qualityze offers clients in the life sciences and manufacturing industries a preconfigured QMS solution and custom…
Price Range
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Starting Price
$2,000/month/user
Client OS
Web
Deployment
Cloud Hosted
iAudited Screenshot
iAudited
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(1)
iAudited is a Layered Process Audit (LPA) software that guarantees tangible reduction in your quality costs and defects with a money-back guarantee. Meet your regulatory (CQI-8, ISO, IATF and VDA) requirements of internal…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$12/month/user
Client OS
Web, iOS, Android
Deployment
Cloud or On-Premises
EtQ Reliance Screenshot
EtQ Reliance
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★★★★★
(1)
EtQ Reliance is an EHS and quality management system that is designed to manage critical business processes and improve overall quality. EtQ Reliance is easy to use and flexible to meet your unique business requirements. This…
Client OS
Web
Deployment
Cloud Hosted
Apriso Quality Solution Screenshot
Apriso Quality solution from Dassault Systems is an Enterprise Quality Management Software (EQMS) designed specifically for manufacturers. It provides a comprehensive offering designed specifically to address the complexities…
Client OS
Web, Windows
Deployment
Cloud Hosted
isoTracker Screenshot
isoTracker
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(4)
isoTracker is a cloud-based online document control and quality management system that brings together all the tools required for Quality, Environmental, Health and Safety and Compliance management. Easy to Use — Intuitive…
Client OS
Windows
BatchMaster ERP Screenshot
BatchMaster ERP
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(3)
BatchMaster Software is 100% focused on developing and delivering process manufacturing software solutions to the food, chemical, nutraceutical and pharmaceutical industries. BatchMaster Manufacturing is a formula based…
Price Range
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   $     $     $     $     $   
Starting Price
$2,000/user (perpetual license)
Client OS
Android, Web, Windows, iOS
Deployment
Cloud or On-Premises
Arena PLM Screenshot
Arena PLM
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Arena PLM is a product lifecycle management tool to streamline your product development processes. Arena PLM empowers companies to deliver innovative products. Arena PLM is a single place to aggregate product information and…
Client OS
Web
Deployment
Cloud Hosted
Quality Essentials Suite Screenshot
The Quality Essentials Suite from Horizons International is designed to support manufacturers in collecting and measuring their quality performance data throughout their manufacturing operations so that it is accessible for…
Client OS
Windows
uniPoint Screenshot
uniPoint
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uniPoint’s configure-to-order suite of Core, Add-on and Web Modules are designed to help your company automate its journey toward excellence. With twenty-two integrated software modules for quality and compliance management…
Client OS
Windows
Deployment
On-Premises
Orienge Quality Management Screenshot
The solution allows quality specialists to plan and carry out internal audits, detect and deal with inconsistencies, take corrective and preventive actions, analyze consumers’ satisfaction, provide objective data for…
MQ1 Screenshot
MQ1
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Our MQ1 technology is a suite of enterprise-wide quality management software. From the plant floor to the boardroom, CEBOS’ quality management software system enables organizations to save thousands of hours complying with…
Propel Screenshot
Propel PLM is a cloud software solution built on Salesforce that helps companies work with their customers to get better products to market faster. Propel offers a robust and secure product that provides: Product Lifecycle…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$90/month/user
Client OS
Web
Deployment
Cloud Hosted

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CAPA Software Buyer’s Guide

What is CAPA Software?

Corrective and preventive action software (CAPA software) is a continuous improvement tool that collects and analyzes data to identify and eliminate product quality issues, process inefficiencies, and equipment issues. Corrective action in software prevents nonconformities from recurring by eliminating the cause of a nonconformity, while the preventive action prevents nonconformance from occurring at all.

CAPA software provides risk assessments, alerting you to any potential issues that might arise. This allows you to make changes as needed before a problem occurs. When issues occur, the software will assist with root cause analysis to determine why the issue happened and what can be done to fix it.

CAPA software is used by any business that uses a quality control system. The most common use case for CAPA software is by manufacturers that need to ensure their processes and products meet regulatory standards for their industry.

CAPA management systems are typically integrated as part of a larger quality management system instead of being sold as a single standalone solution. The CAPA system can use data from various parts of the quality system including customer complaints, document management systems, and audit management systems.

Features of CAPA Software

Feature Description
Root Cause Analysis Identifies the underlying problem with a product or process.
Corrective Action Planning Define tasks that will correct noncompliance or issues with a product or process.
Risk Assessment Identify potential problems with product quality and processes. Create preventive action plans to mitigate risk.
Reporting Create reports on the entire CAPA process including errors reported, risk assessment results, CAPA workflow tasks completed, real-time equipment performance, customer complaints, and more.

Benefits of CAPA Software

Identify Product and Process Issues with Root Cause Analysis

CAPA management software helps identify and define the underlying quality issue or process failure. The software will alert you in real-time when an issue occurs and provide you with details about what may have caused the problem. More details about the error can be recorded within the software in case the same issue recurs.

Root cause analysis assists personnel with the creation of corrective action plans. Knowing when, where, and why a problem occurred makes it easier to quickly correct it and reduce downtime. This information is then used as the base for corrective action planning.

Root cause investigation results in MasterControl Qx
Root cause investigation results in MasterControl Qx.

Create Plans to Effectively Fix Product Quality or Process Issues

Corrective action software facilitates the creation of corrective action plans. A corrective action plan is a set of instructions that need to be followed in order to correct an issue with product quality or performance. Information from a root cause analysis is most typically used to create a corrective action plan. CAPA software also allows you to assign qualified personnel to tasks with the corrective action plan.

Information from audits can also be used to create corrective action plans. If a process or product quality issue is discovered from an audit and doesn’t meet regulatory requirements, the problem must be corrected immediately. The corrective action plan will define the steps that need to be taken to fix any issues and due dates for the corrections. CAPA software will document the actions taken for follow-up audits.

Corrective action plans are also useful outside manufacturing processes and product quality corrections. For example, corrective action plans can be made for employee performance improvements. The plan will define expectations and steps to take to improve performance.

Corrective action details in HQMS
Corrective action details in HQMS.

Reduce Risk and Prevent Quality Issues

CAPA software records data from risk assessments to determine if any problems will occur during or after the manufacturing process. The information gathered from the risk assessment can then be used to create preventive action plans. These plans define the steps to take to prevent a problem with a process or product from happening.

The software can monitor various types of risks including financial risks, operational risks, human resources risks, and more. When potential risks are found, the software will notify you to take preventive action. Risk assessments can be scheduled within the software to occur as frequently as you want.

he risk assessment tool in BPA Quality
The risk assessment tool in BPA Quality monitors risk sources, the number of risks identified, and types of risks including production failure risks, liability risks, demand risks, transportation and handling risks, and more.

Gain Valuable Insights Into Quality Issues and Potential Risks

Reporting functionality in CAPA software gives businesses valuable insights into problems and potential risks that could negatively impact a company’s ROI, compliance status, and reputation. A few of the areas reports can be run on include risk assessment results, root cause analysis results, corrective and preventive actions taken, equipment performance, and more. The information can be laid out in dashboards, providing you with an easy to use graphical representation of your data.

When your CAPA solution is tied together with a quality system, you can also run reports on other metrics like customer complaints and audit results. Having this information together in one system allows you to have better control over your CAPA processes.

The complaint dashboard in ComplianceQuest
The complaint dashboard in ComplianceQuest provides graphical representations of complaints by customer and product, the number of complaints, and more.

Maintain Regulatory Compliance for Your Industry

CAPA software helps manufacturers maintain regulatory compliance. Different CAPA solutions can be geared towards different industries like medical device manufacturers, life sciences, food and beverage manufacturers, and automotive manufacturers. Certain products need to meet specific quality standards in regards to physical makeup or size specifications. Packaging and labeling can be required and strictly regulated. CAPA software can help manufacturers take the proper steps to ensure their business is meeting all regulatory requirements. If a step is missed at any point in the manufacturing process, the system will alert you to take action before a problem occurs.

Some regulatory compliances that CAPA systems can assist with include:

  • ISO 9001
  • GMP
  • FDA Title 21 CFR Part 11
  • HAACP
  • IATF 16949

Cost of CAPA Software

We’ve seen CAPA software anywhere from $12/month/user to $2,000/month/user. Of course, there are many solutions that fall between this range. The cost of CAPA software varies greatly depending on a number of factors including the type of software, the number of users, and software deployment. Many solutions offer a free trial period for you to test out the product before committing.

On the lower end, a solution like iAudited starts at $12/month/user and helps with audit management, corrective action tracking, and team collaboration. This solution is meant for assisting businesses with their auditing process.

On the higher end, a full quality management system like Qualityze starts at $2,000/month/user and includes features like nonconformance management, CAPA management, change management, audit management, compliant management, and more. Full QMS solutions are ideal for businesses that need to manage all quality processes.