AssurX

Regulatory compliance & quality management software system

4,6 /5 (22 reviews) Write a Review!

AssurX Overview

What is AssurX?

AssurX is a quality management & regulatory compliance platform for highly regulated industries, including energy & utilities, life sciences, manufacturing, food & beverage, and high tech manufacturers. The solution offers tools for managing audits, complaints, documents, risks, training, compliance, and more.

AssurX's audit management system enables the planning, scheduling, and running of any kind of audit. Corrective and preventive actions (CAPA) can be launched from within the system, with tools for root cause analysis, action planning, implementation, and review. Complaints handling processes can be automated according to industry best practices for compliant documentation and reporting of complaints. AssurX also assist companies with maintaining compliance through central organization, tracking, and coordination of all compliance evidence, requirements, history, schedules, and activity for risk control and regulatory reporting.

AssurX includes a document management module which allows users to create, review, modify and distribute documents, with all revisions and document histories stored in a secure central repository. AssurX also offers modules for managing training, risks, changes, patches, manufacturing quality, supplier quality, and more.

AssurX Overview

Pricing

Starting from
N/A

Pricing options

Free Trial
Subscription
Value for money

Contact AssurX for pricing information.


AssurX Features

Devices
Business size
S M L
Markets
United States, Canada, United Kingdom, Australia, India, Germany, Mexico
Supported Languages
Chinese (Simplified), Danish, Dutch, English, Finnish and 9 others, French, German, Italian, Japanese, Norwegian, Portuguese, Spanish, Swedish, Thai

Media

AssurX video

AssurX Reviews

AssurX Reviews

Overall rating
4,6
/
5
Excellent
15

Very good
6

Average
1

Poor
0

Terrible
0

Value for Money
4,7
Features
4,5
Ease of Use
4,2
Customer Support
4,9
95% recommended this app
Verified Reviewer

An agile solution that doesn't compromise on compliance.

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.


Kevin F.

Great flexible solution and a great team to work with from selection to implementation & use

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.


Luann S.

Ease of program

setting up new modules


William T.

Powerful Flexable Tool

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.


Bryan S.

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


Verified Reviewer
Industry: Biotechnology
Company size: 10 000+ Employees

An agile solution that doesn't compromise on compliance.

Used Daily for 2+ years
Reviewed on 2018/10/18
Review Source: Capterra

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.

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Kevin F.
Industry: Medical Devices
Company size: 501-1 000 Employees

Great flexible solution and a great team to work with from selection to implementation & use

Used Daily for 1+ year
Reviewed on 2020/06/22
Review Source: SoftwareAdvice

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.

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Luann S.
Industry: Electrical/Electronic Manufacturing
Company size: 51-200 Employees

Ease of program

Used Daily for 2+ years
Reviewed on 2020/06/11
Review Source: SoftwareAdvice

setting up new modules

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 8.0/10

William T.
Industry: Utilities
Company size: 501-1 000 Employees

Powerful Flexable Tool

Used Daily for 2+ years
Reviewed on 2020/06/16
Review Source: SoftwareAdvice

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.

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Bryan S.

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

Used Daily for 2+ years
Reviewed on 2018/01/30
Review Source: Capterra

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

User recommendation
9,1/10
Based on 22 user ratings
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AssurX Pricing

AssurX Pricing

Starting from
N/A
Free Trial
Subscription
Value for money

Contact AssurX for pricing information.

Contact AssurX for pricing information.

Value for Money
4,7/5
Based on 22 user ratings
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AssurX Features

AssurX Features

API
Activity Dashboard
Activity Tracking
Audit Trail
Auditing
Automatic Notifications
Billing & Invoicing
Compliance Management
Customizable Reporting
Data Import/Export
Document Management
Document Storage
Inventory Management
Inventory Tracking
Monitoring
Real Time Data
Real Time Reporting
Reporting & Statistics
Third Party Integration
Workflow Management
Features
4,5/5
Based on 22 user ratings
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Categories

Additional information for AssurX

Additional information for AssurX

Key features of AssurX

  • Audit Management
  • Corrective Actions (CAPA)
  • ISO Compliance
  • ISO Standards Management
  • Knowledge Management
  • Maintenance Management
  • Nonconformance Tracking
  • OSHA Compliance
  • Risk Management

Benefits

Automate notifications, escalations, routing, and approvals for any process.

Launch corrective and preventive actions (CAPAs) from any point in any process.

Accelerate response to issues caused by unexpected failures, defects, and other nonconformances.

Electronically submit vigilance and adverse event reports based on regional submission requirements.

Track and monitor the performance of processes and products throughout their lifecycle. Plan and facilitate GxP audits and inspection.

Build out and integrate processes as required; expand your quality ecosystem to meet your needs.

Deploy AssurX as an onsite solution, in the AssurX Cloud QMS™, or as a hybrid solution.

AssurX FAQs

AssurX FAQs

Below are some frequently asked questions for AssurX.

Q. What type of pricing plans does AssurX offer?

AssurX offers the following pricing plans:

Pricing model: Subscription

Free Trial: Not Available

Contact AssurX for pricing information.

Q. What are the main features of AssurX?

AssurX offers the following features:

  • Audit Management
  • Corrective Actions (CAPA)
  • ISO Compliance
  • ISO Standards Management
  • Knowledge Management
  • Maintenance Management
  • Nonconformance Tracking
  • OSHA Compliance
  • Risk Management

Q. Who are the typical users of AssurX?

AssurX has the following typical customers:

Large Enterprises, Mid Size Business

Q. What languages does AssurX support?

AssurX supports the following languages:

Chinese (Simplified), Danish, Dutch, English, Finnish, French, German, Italian, Japanese, Norwegian, Portuguese, Spanish, Swedish, Thai

Q. What type of pricing plans does AssurX offer?

AssurX has the following pricing plans:

Subscription

Q. Does AssurX support mobile devices?

We do not have any information about what devices AssurX supports

Q. What other apps does AssurX integrate with?

AssurX integrates with the following applications:

Blue Link ERP, Microsoft 365, Microsoft Azure, Microsoft Dynamics 365 Business Central, NetSuite, Oracle CRM On Demand, SAP Business ByDesign, SAP Business One, SAP CRM, Salesforce App Cloud

Q. What level of support does AssurX offer?

AssurX offers the following support options:

Phone Support, Online Support, Video Tutorials