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AssurX

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AssurX 2026: Benefits, Features & Pricing

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  • Overview
  • Pricing and Plans
  • Features
  • Integrations
  • User Reviews

Overview

AssurX
AssurX
4.6
(25)

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

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AssurX Pricing and Plans

Free Trial
Free Version

Pricing available upon request

No plan information available

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    AssurX Features

    • Popular features found in Quality Management
      Change Management
      Complaint Management
      Corrective and Preventive Actions (CAPA)
      Defect Tracking
      Document Management
      Electronic Signature
      Incident Management
      Quality Control
      Risk Management
      Task Management
      Training Management
    • More features of AssurX
      Access Controls/Permissions
      Activity Dashboard
      Activity Tracking
      Alerts/Escalation
      Alerts/Notifications
      API
      Approval Process Control
      Archiving & Retention
      Audit Management
      Audit Planning
      Audit Trail
      Calibration Management
      Collaboration Tools
      Compliance Management
      Compliance Tracking
      Customization
      Dashboard
      Data Collection
      Data Import/Export
      Data Visualization
      Digital Signature
      Document Coding & Control
      Document Storage
      EDI
      Environmental Compliance
      FDA Compliance
      Hazardous Materials Management
      HIPAA Compliant
      Inspection Management
      ISO Compliance
      ISO Standards Management
      Issue Management
      Maintenance Management
      Monitoring
      Nonconformance Tracking
      OSHA Compliance
      OSHA Recordkeeping
      Performance Metrics
      Real-Time Analytics
      Real-Time Data
      Real-Time Updates
      Regulatory Reporting
      Reporting/Analytics
      Reporting & Statistics
      Risk Assessment
      Root Cause Analysis
      Safety Management
      Safety Training Management
      Scheduling
      Status Tracking
      Supplier Management
      Supplier Quality Control
      Sustainability Management
      Third-Party Integrations
      Trend Analysis
      Version Control
      Workflow Management

    AssurX Integrations

    SAP Business ByDesign
    SAP Business ByDesign
    Oracle Cloud Infrastructure (OCI)
    Oracle Cloud Infrastructure (OCI)
    Agile CRM
    Agile CRM
    Blue Link ERP
    Blue Link ERP
    Oracle CRM On Demand
    Oracle CRM On Demand
    Salesforce Platform
    Salesforce Platform

    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

    VR

    Verified
    Reviewer

    Biotechnology

    10000+ employees

    Used daily for more than 2 years

    Review source

    Reviewed 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

    4
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    A low-code, agile software tool, with the ability to customize workflow applications without relying on software developers. Comes with comprehensive 21CFRPart11 compliance features that – when implemented correctly - satisfy FDA computer system compliance requirements. We report using Crystal, with end users entering their own parameters and executing without any software needed on client machines – which has worked very well for us. AssurX support has been outstanding. CATSWeb can be as simple or as complex as you need it to be, and with a comprehensive API, the possibilities are limitless for customizations and integration with other systems. We have yet to encounter any technical constraints with this tool. If implemented correctly, CATSWeb can automate many of your internal business processes and return great value to your organization.
    Cons:
    Due to its highly configurable nature, requires solid, internal process controls for development activities (standardizing naming conventions, documentation of changes, governance etc.). To deal with this, we built an internal change management workflow directly within CATSWeb that captures all system changes – big and small – which has been incredibly effective. Any modification to our applications is linked to a change record that documents the reason for change, the actual change plan, the verification steps, and the review signatures. This has made the evolution of our workflows clean and efficient. Any software with extensive functionality is going to come with a significant learning curve, and CATSWeb is no different. Our recommendation is to assign a dedicated CATSWeb SME to learn the system and develop your applications. Investing in training early will pay back in spades down the road.

    Read More

    KF

    Kevin F.

    Verified reviewer

    Medical Devices

    501-1000 employees

    Used daily for less than 2 years

    Review source

    Reviewed 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

    4
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    The pre-configured solutions were a bonus and helped make our decision on selection, even though the initial solutions we wanted to go-live with weren't good fits, the ease of configuration won us over. We selected this product on seeing an older interface, but when we came to implementation AssurX had developed a new interface which has been a huge help in making the system more user friendly and making it appear more modern to the users. I must say the AssurX team have been great to work with, from initial contact with Sales, to the onboarding, install, implementation support from their Professional Services and Validation support. Everyone has been so helpful and supportive and we couldn't have met our objective set by our senior management without them.
    Cons:
    Whilst the configuration and flexibility has been great, I suppose its a double edged sword. We have been fortunate to have our own software developer at AMS, who has helped us navigate some of the advanced configuration which we would have probably struggled with. Whilst the initial training was necessary to gain and understanding of the fundamentals there is actually so much more to learn from the system, so I'm glad there seems to be more advanced training topics on specific areas. We could have built a process on the basic training but we have such a better process now from using the advanced tools, especially when we had a wide range of multiple sites as our customers. The Graphics for charts and KPI metrics whilst being functional, do look outdated in comparison to what is out there from some of the other suppliers. I believe there is a project to improve this which I can't wait to see. The Validation is a lot more manual, some suppliers offered what looked like a more automated package, although we will never know if this was the case. Again, there is some good work coming from the Validation team on improvements and looking forward to seeing a project they are working on to make validation more automated.

    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

    Read More

    LS

    LuAnn S.

    Verified reviewer

    Electrical/ Electronic Manufacturing

    51-200 employees

    Used daily for more than 2 years

    Review source

    Reviewed June 2020

    Ease of program

    3

    setting up new modules

    Ratings Breakdown

    3
    Ease of use
    3
    Value for money
    3
    Customer support
    4
    Functionality
    icon
    Pros:
    the ease for queries. we can have this build to meet our needs.
    Cons:
    Better merge with company ERP system. should have more training once up and running admins should have the know ow to make format changes.

    Reasons for choosing AssurX

    i wasn't involved at that time, i was shown after the fact

    Read More

    WT

    William T.

    Verified reviewer

    Utilities

    501-1000 employees

    Used daily for more than 2 years

    Review source

    Reviewed 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

    4
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    The basic EUEM Electric Utility Package allows easy compliance evidence collection task scheduling and oversight. The software is powerful and flexible enough to allow configuration and customization to allow complex automated notifications and evidence collection based on circumstances.
    Cons:
    Because it is so powerful and can be configured to do almost anything, the configuration process and learning curve can be intimidating. Although the EUEM utilities package is well developed for basic use. AssurX was unable to provide a roadmap for implementing it for my system. Basically I was handed the software and told to implement it. There was little guidance as to what questions I needed to ask myself about what I wanted the software to do or guidance as to best practices for implementation. I felt like I was reinventing the wheel.

    Reasons for choosing AssurX

    Competitive price, and superior Configuration and interface.

    Read More

    PB

    Paul B.

    Verified reviewer

    Computer Hardware

    51-200 employees

    Used daily for more than 2 years

    Review source

    Reviewed 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

    3
    Ease of use
    4
    Value for money
    5
    Customer support
    4
    Functionality
    icon
    Pros:
    Great flexibility in configuration, covers complete range of quality and compliance needs. Cloud base saves on support issues. Ability to tailor implementation to specific needs. Link to ERP system is seamless. When proper time is spent planning implementation and configuring to specific needs the product is very easy to use and well received.
    Cons:
    Key is with implementation, the software is very flexible and can lead to issues if not configured to match business needs. Configuration tools are easily accesses but documentation is light, requires resource training and time or use of consulting services. Consulting services are very good but have cost associated. Pricing structure is less attractive as user licenses increase.

    Read More

    RF

    Ron F.

    Verified reviewer

    Medical Devices

    10000+ employees

    Used daily for more than 2 years

    Review source

    Reviewed 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

    5
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    The ability to quickly develop, validate and deploy any work flow process using internal developers.
    Cons:
    My previous greatest concern has now been addressed with the release of V8 which now utilizes Unicode which allows us to enter, store and share data entered using double byte character sets like Chinese, Japanese and Korean.

    Reasons for choosing AssurX

    Ease of configurability. Concurrent licenses. Part 11 complaint. Ability to easily export data from CATSWeb for further analysis if desired.

    Read More

    BS

    Bryan S.

    Used daily for more than 2 years

    Review source

    Reviewed January 2018

    Working with the group at AssurX has been great. Very supportive and collaborative.

    4

    Ratings Breakdown

    3
    Ease of use
    4
    Value for money
    5
    Customer support
    4
    Functionality
    icon
    Pros:
    All of our processes are in one place. We currently have 7 processes in CATSWeb. The system is extremely customizable to fit your system requirements. Working with AssurX is great. They are very responsive to your questions and will work with you to solve a problem you are having. CATSWeb offers several starting points for a wide number of process that you can then customize to fit your needs.
    Cons:
    Every system out there is going to have its quirks. One system may have a few more features than another and that is true with CATSWeb. We have found that because CATSWeb is so customizable, that puts more of a burden on the customer to have an extremely strong requirements document up front. Don't assume that the system will do something for you. Make sure it is listed as a requirement.

    Read More

    DL

    Deb L.

    Used daily for more than 2 years

    Review source

    Reviewed December 2017

    We have had AssurX software for about 8 years now and have been happy customers.

    5

    Ratings Breakdown

    4
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    It is extremely customizable. You can enhance current forms and processes or you can create your own. It seems than anything you can dream up, you can create. The tracking features, notifications and interactive dashboards are extremely helpful. A picture (dashboards) is worth a thousand words for our management team. The support staff is very knowledgeable and helpful.
    Cons:
    Our users sometimes have a hard time moving between screens to see all information within the processes. They find themselves clicking back a lot and have a hard time searching for items. Also, at user conferences we see a lot of great new things and it seems to take a significant amount of time to actually get them.

    Read More

    RS

    Robin S.

    Verified reviewer

    Medical Devices

    1001-5000 employees

    Used daily for less than 2 years

    Review source

    Reviewed June 2020

    Excellent Product and service

    5

    Ratings Breakdown

    5
    Ease of use
    5
    Value for money
    5
    Customer support
    5
    Functionality
    icon
    Pros:
    The system is completely flexible and it's use is limited only by your imagination. The support we have received from the company has been excellent, nothing is too much trouble and they are always willing to engage with you to assist as much as they can.
    Cons:
    Because the system has such flexibility, this can lead to a daunting array of configuration options. You will need some degree of IT technical expertise to get the maximum out of the system, but with it anything is possible.

    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.

    Read More

    LP

    Lou P.

    Verified reviewer

    Pharmaceuticals

    501-1000 employees

    Used daily for more than 2 years

    Review source

    Reviewed 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

    3
    Ease of use
    5
    Value for money
    5
    Customer support
    3
    Functionality
    icon
    Pros:
    It is flexible to manage multiple quality processes.
    Cons:
    The programming options are limited and integration with other systems is clunky.

    Reasons for choosing AssurX

    it was before I took over the IT ownership of the product.

    Read More

    Showing 1 - 10 of 25 Reviews

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