The Best CAPA Software

Get the best software for your business. Compare product reviews, pricing below.

Talk with a software advisor
Talk with an advisor
Get a free consultation from an independent expert.
Or, call toll-free: (800) 827-1151
Talk with a software advisor
Talk with an advisor

Popular Products

No products found
Intellect QMS Screenshot
Intellect QMS is a quality management software that helps leaders meet FDA, ISO, and other global GxP regulatory compliance reuqirements. The software aids to accelerate compliance, empower adaptability and your remote workforce. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. @youtube
Deployment
Cloud or On-Premises
TRACKMEDIUM Screenshot

TRACKMEDIUM

★★★★★
★★★★★
(2)
TRACKMEDIUM is a cloud-based quality management system (QMS) with a subscription-based service which can be accessed from any web browser making it ideal for small to medium businesses (SMEs). The platform is preloaded with all the needed quality management modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), Gage Management, Training Management, and many more. Just load your users, customers, suppliers and drop-down options and you
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$299/month
Client OS
iOS, Android, Web
Deployment
Cloud Hosted
HQMS Screenshot

HQMS

★★★★★
★★★★★
(3)
Harrington Quality Management Software (HQMS) is the flagship world-class software for process improvement, compliance and EQMS Online Quality Management Software System. It addresses the needs of manufacturing, aerospace, medical device, pharmaceutical, healthcare, government and other service industries. EQMS was designed to manage five key drivers of shareholder value: customers, employees, supply chain, products, and services. It is an “all-in-one” solution. The Harrington’s quality control
Client OS
Windows, Web
Deployment
Cloud or On-Premises
Qualcy eQMS Screenshot

Qualcy eQMS

★★★★★
★★★★★
(2)
Qualcy is a web-based QMS software supports document, training, supplier quality, and equipment management. It also offers non-conformance, CAPA, and auditing features. Qualcy meets 21 CFR 820, 210, 211 and ISO 13485 standards.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$799/month
Client OS
Web
Deployment
Cloud or On-Premises
MasterControl Qx Screenshot

MasterControl Qx

★★★★★
★★★★★
(1)
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 the product lifecycle from conception to manufacturing and delivery. Quality can never be a differentiator if it’s an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible and compliance issues a
Client OS
Web
Deployment
Cloud Hosted
AssurX Screenshot

AssurX

★★★★★
★★★★★
(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 sciences, energy and utilities, and more. Corrective Action, Preventive Action (CAPA); Audit Management; Complaint Handling; Quality Management; Document Management; Change Control; Supplier Quality Management; Training Management; Customer Quality Management; Risk
Client OS
Web
Deployment
Cloud or On-Premises
TrackWise Screenshot

TrackWise

★★★★★
★★★★★
(1)
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. Commonly known as QMS software, TrackWise software is the only enterprise quality management solution that offers the flexibility and configurability to adapt to company-specific requirements and business processes, enabling clients to define, track, manage, and report on the core
ComplianceQuest Screenshot

ComplianceQuest

★★★★★
★★★★★
(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 secure system. ComplianceQuest helps businesses manage a variety of compliance regulations including, but not limited to, ISO 9001, FDA 21 CFR Part 11, and IATF 16949. Audit Management; CAPA; Change Management; Complaints Management; Document Management; Incident Management;
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$20/user/month
Client OS
Web
Deployment
Cloud Hosted
Infor Fourth Shift Screenshot

Infor Fourth Shift

★★★★★
★★★★★
(4)
Infor Fourth Shift offers capabilities that are critical for small to medium-sized manufacturers. These include using data for decision-making across manufacturing flow, coordinating financial and production operations, optimizing end-to-end supply chain management, maintaining product quality standards, and improving collaboration with various stakeholders.
Client OS
Windows
Deployment
On-Premises
IQS Screenshot

IQS

★★★★★
★★★★★
(2)
IQS was a quality and compliance management software system acquired by Cority in 2017.
Client OS
Windows
Deployment
Cloud Hosted
SmartSolve eQMS Screenshot
SmartSolve eQMS, developed by Pilgrim Quality Solutions, an IQVIA company, is designed to simplify quality compliance management in life science industries. A next-generation quality management solution, it focuses on improving product quality, ensuring patient safety, and maintaining regulatory compliance through a modular, integrated approach. Powered by IQVIA Connected Intelligence, SmartSolve eQMS offers uses an interconnected approach to drive operational efficiencies and improve compliance performance​​. The SmartSolve Postmarket Surveillance module eliminates manual tasks to accelerate the delivery of safer and more effective products. The Regulatory Connector feature simplifies, automates, and integrates compliance response times​​.
Client OS
Web
Deployment
Cloud Hosted
Qualityze Screenshot

Qualityze

★★★★★
★★★★★
(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 solutions with high quality that are cost-effective. The solution is Salesforce Lightning Certified. Nonconformance Management; CAPA Management; Change Management; Document Management; Audit Management; Complaint Management; Training Management; and Supplier Management. Life
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$2,000/user/month
Client OS
Web
Deployment
Cloud Hosted
iAudited Screenshot

iAudited

★★★★★
★★★★★
(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 audits and safety (OSHA & ISO 14001) compliance. iAudited provides the most advanced set of features including corrective action tracking, trend charts and top-n analysis, video cues for auditors, geo-tagging, AI-driven predictive engine and end-to-end encryption. With mobile
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$12/user/month
Client OS
iOS, Android, Web
Deployment
Cloud or On-Premises
EtQ Reliance Screenshot

EtQ Reliance

★★★★★
★★★★★
(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 solution is web-based, allowing for fast implementation and frequent updates. @youtube Document Control; Employee Training Management; Audits Management; Corrective Action/Preventive Action (CAPA); Change Management; Suppliers, Materials, and Chemicals Management; Risk
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 of managing quality on a global scale. Built on Apriso applications that function like a platform for manufacturing operations management, sharing a common data model and database, this solution can unify and standardize quality management across your enterprise. It helps
Client OS
Windows, Web
Deployment
Cloud Hosted
isoTracker Screenshot

isoTracker

★★★★★
★★★★★
(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 structure that requires little training; Affordable — Provides a quick return on your investment (ROI); Reliable & Secure — Centralized repository with daily back-ups; Facilitates Improvement — Leading to better results; Comprehensive Solution — Document Control, Customer
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$84/month
Client OS
Windows
Deployment
Cloud Hosted
BatchMaster ERP Screenshot

BatchMaster ERP

★★★★★
★★★★★
(4)
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, process manufacturing application that supports R&D, formulation, packaging, costing, production, QC, QA, inventory, compliance, and traceability. Optional modules include sample management, planning (MRP), scheduling (MPS), warehousing, alert management, and EDI exchange. These
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$2,000/user (perpetual license)
Client OS
Windows, iOS, Android, Web
Deployment
Cloud or On-Premises
Arena PLM Screenshot

Arena PLM

★★★★★
★★★★★
(4)
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 related processes. Arena PLM provides a critical foundation to capture your electrical, mechanical, software, and firmware design along with associated documentation. Arena PLM lets you track a complete history for your bill of materials. Arena PLM accelerates engineering
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 analysis and reporting in a timely manner. Reduce compliance costs by quickly recording test values for environmental requirements (temperature, moisture content, etc.) or for products (height, weight, silicon %, etc.) during your manufacturing process.; Efficiently manage QA
Client OS
Windows
uniPoint Screenshot

uniPoint

★★★★★
★★★★★
(3)
uniPoint is a configure-to-order QMS solution designed to help your company automate its journey toward excellence.
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$225/user/month
Client OS
Windows, Web
Deployment
Cloud or On-Premises

We searched and searched, but we couldn’t find any products in our database that match your criteria. Perhaps our team of software experts can help? They’d be happy to provide a list of free the best CAPA software recommendations that meet your exact requirements.

Sort by 
Filter by User Rating
Filter by Price Range
Filter by Deployment
Filter by Client OS
LinkedIn
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.