AssurX 2026: Benefits, Features & Pricing
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- Overview
- Pricing and Plans
- Features
- Integrations
- User Reviews
Overview
Pricing
Pricing available upon request
About AssurX
AssurX quality management software platform is a configurable system designed to create connected workflows, enabling a closed-loop quality management system. Built for regulated industries with strict compliance requirements, the platform allows organizations to align quality systems with standards and regulations such as FDA/CGMP, EMA, SEMI, and ISO. This helps minimize risk exposure, address deviations and non-compliance issues proactively, protect data integrity, and manage change effectively. Quality and compliance issues, along with their statuses, can be monitored through built-in dashboards that provide data analysis and reporting, with electronic reporting designed to adhere to regulatory guidelines.
AssurX facilitates electronic workflows that include tasks, alerts, escalations, and approvals, which can be automated to varying degrees. It also integrates with enterprise systems such as ERP, CRM, and PLM to streamline operations further. Organizations can implement the platform starting with critical solutions and expand workflows and applications as their quality systems evolve. Core functionalities include corrective and preventive actions (CAPA), complaints management,...
deviations tracking, change management, audit management, risk management, supplier quality management, document management, and training management. AssurX is available as a cloud-based solution or as an on-premise, platform-agnostic option. Additional services include training, implementation support, and validation management assistance.AssurX Screenshots

AssurX Pricing and Plans
Pricing available upon request
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AssurX Features
- Popular features found in Quality ManagementChange ManagementComplaint ManagementCorrective and Preventive Actions (CAPA)Defect TrackingDocument ManagementElectronic SignatureIncident ManagementQuality ControlRisk ManagementTask ManagementTraining Management
- More features of AssurXAccess Controls/PermissionsActivity DashboardActivity TrackingAlerts/EscalationAlerts/NotificationsAPIApproval Process ControlArchiving & RetentionAudit ManagementAudit PlanningAudit TrailCalibration ManagementCollaboration ToolsCompliance ManagementCompliance TrackingCustomizationDashboardData CollectionData Import/ExportData VisualizationDigital SignatureDocument Coding & ControlDocument StorageEDIEnvironmental ComplianceFDA ComplianceHazardous Materials ManagementHIPAA CompliantInspection ManagementISO ComplianceISO Standards ManagementIssue ManagementMaintenance ManagementMonitoringNonconformance TrackingOSHA ComplianceOSHA RecordkeepingPerformance MetricsReal-Time AnalyticsReal-Time DataReal-Time UpdatesRegulatory ReportingReporting/AnalyticsReporting & StatisticsRisk AssessmentRoot Cause AnalysisSafety ManagementSafety Training ManagementSchedulingStatus TrackingSupplier ManagementSupplier Quality ControlSustainability ManagementThird-Party IntegrationsTrend AnalysisVersion ControlWorkflow Management
AssurX Integrations
See all 18 integrations
AssurX User Reviews
Overall Rating
4.6
Ratings Breakdown
5
64%
4
28%
3
8%
2
0%
1
0%
Secondary Ratings
Ease of Use
4.1
Value for money
4.6
Customer support
4.8
Functionality
4.4
Biotechnology
10000+ employees
Used daily for more than 2 years
Review sourceReviewed October 2018
An agile solution that doesn't compromise on compliance.
5
We are a global drug company with manufacturing sites all over the world. Due to nature of the data in our system (product complaint investigations), we are continuously under inspection. In the 10+ years that we’ve been using CATSWeb, there hasn’t been a single observation regarding any of the system functionalities. The compliance features (record archiving, audit trails, eSig controls etc.) are comprehensive, easy to use, and reliable. In addition to compliance, the big benefit of CATSWeb is its agility. As a low code platform, we were able to train 1-2 Business Analysts (non-programmers) to develop and maintain our own applications without relying on software developers and our internal IT organization. With good process controls in place, workflow modifications happen in days (not weeks or months), thus avoiding costly development and software validation efforts. We have the capacity to deliver new functionality to users quicker than internal procedures can get updated, and without software engineers, DBAs, and project managers getting involved.
Ratings Breakdown
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Kevin F.
Verified reviewer
Medical Devices
501-1000 employees
Used daily for less than 2 years
Review sourceReviewed June 2020
Great flexible solution and a great team to work with from selection to implementation & use
5
We are hoping to transform our whole QMS with AssurX. Everything is currently manual on paper forms, but also because we are a growing company through various acquisitions, all sites work in different ways. So we are taking this as an opportunity to standardise where we can. We will be taking various approaches of configuring and using some pre-configured solutions. We went live earlier this year with our NC and CAPA solution and working on Document Management and Complaints this year. Overall its probably a five year plan. Overall we are really happy and they are great people to work with, they never complain about the many questions we ask, and we ask a lot, sometimes the same question because there is so much we are learning.
Ratings Breakdown
Reasons for choosing AssurX
We did a comprehensive assessment of various systems. Overall functionally AssurX and one other product was by far the top preferences for functionality. Then we assess all factors such as Validation and Cost and services provided. It was close, but overall the cost of concurrent licenses and on premise install w ere the clinchers, this meant whilst the initial cost was high, over time it was the best value product.
Vendor Response
AssurX has since updated its graphics for charts and KPI metrics.
Replied July 2022
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LuAnn S.
Verified reviewer
Electrical/ Electronic Manufacturing
51-200 employees
Used daily for more than 2 years
Review sourceReviewed June 2020
Ease of program
3
setting up new modules
Ratings Breakdown
Reasons for choosing AssurX
i wasn't involved at that time, i was shown after the fact
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William T.
Verified reviewer
Utilities
501-1000 employees
Used daily for more than 2 years
Review sourceReviewed June 2020
Powerful Flexable Tool
5
My utility first developed a manual system built around AssurX to identify and trigger event driven tasks when the software, later with the help of AssurX services, an automated system was implemented based on the manual system that we developed. AssurX support and development is first rate and my experience has been overwhelmingly positive. My Representative [SENSITIVE CONTENT HIDDEN] has always provided quick response and has always provided a solution that resolves the issue or request.
Ratings Breakdown
Reasons for choosing AssurX
Competitive price, and superior Configuration and interface.
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Paul B.
Verified reviewer
Computer Hardware
51-200 employees
Used daily for more than 2 years
Review sourceReviewed January 2021
AssurX Review
5
We are using for corrective and preventative actions, manufacturing and supplier non-conforming part tracking, internal ISO9001 audits and RMA repair activity. Tracking CAPA progress, reporting activity to suppliers and customers and exporting data for reporting is all much easier with the software. Customer audits score higher due to controls established with software.
Ratings Breakdown
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Ron F.
Verified reviewer
Medical Devices
10000+ employees
Used daily for more than 2 years
Review sourceReviewed June 2020
AssurX CATSWeb QMS application has stood the test of time
5
The system is very flexible and has allowed us to continually expand our QMS applications. Concurrent licenses have been extremely beneficial in helping us to minimize our cost of ownership. The team at AssurX has been very responsive and helpful when we have experienced any technical issues.
Ratings Breakdown
Reasons for choosing AssurX
Ease of configurability. Concurrent licenses. Part 11 complaint. Ability to easily export data from CATSWeb for further analysis if desired.
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Bryan S.
Used daily for more than 2 years
Review sourceReviewed January 2018
Working with the group at AssurX has been great. Very supportive and collaborative.
4
Ratings Breakdown
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Deb L.
Used daily for more than 2 years
Review sourceReviewed December 2017
We have had AssurX software for about 8 years now and have been happy customers.
5
Ratings Breakdown
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Robin S.
Verified reviewer
Medical Devices
1001-5000 employees
Used daily for less than 2 years
Review sourceReviewed June 2020
Excellent Product and service
5
Ratings Breakdown
Reasons for choosing AssurX
The product does the job we need it to do at a price point which makes a very compelling business case.
Reasons for switching to AssurX
We needed one coherent joint up system.
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Lou P.
Verified reviewer
Pharmaceuticals
501-1000 employees
Used daily for more than 2 years
Review sourceReviewed June 2020
QMS CATSWEb processes
4
The organization must use CATSWEB for training, CAPA, Deviation and 6 other processes. The users struggle to navigate the system particularly if they do not use the system daily. The Training process is the simplest and users do not have any issues with the simple execution of read and acknowledged training.
Ratings Breakdown
Reasons for choosing AssurX
it was before I took over the IT ownership of the product.
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