AssurX

4.6 (25)
Write a Review!
Regulatory compliance & quality management software system

About 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.


Key benefits of AssurX

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.


Images

View 1 more
AssurX video

Not sure about AssurX? Compare with a popular alternative

AssurX

4.6 (25)
VS.
Highly reviewed

Starting Price

No pricing found
US$1,700.00
year

Pricing Options

Free version
Free trial
Free version
Free trial

Features

44
241

Integrations

13
2

Ease of Use

4.1 (25)
4.6 (95)

Value for Money

4.6 (25)
4.7 (95)

Customer Service

4.8 (25)
4.7 (95)
Green rating bars show the winning product based on the average rating and number of reviews.

Alternatives

QT9 QMS

4.7
#1 Alternative to AssurX
The most adaptable & easy to use quality management software. The QT9 QMS is a highly modular web-based system designed...

MasterControl Manufacturing Excellence

4.5
#2 Alternative to AssurX
MasterControl Manufacturing Excellence is a SaaS platform designed to help businesses streamline inventory tracking,...

Greenlight Guru

4.4
#3 Alternative to AssurX
Greenlight Guru helps medical device businesses create, launch, and manage custom workflow templates to streamline...

ETQ Reliance

4.6
#4 Alternative to AssurX
ETQ Reliance is a cloud-native QMS powered by an agile platform that drives 40 best-in class applications adaptable to...

Reviews

Overall rating

4.6 /5
(25)
Value for Money
4.6/5
Features
4.4/5
Ease of Use
4.1/5
Customer Support
4.8/5

Already have AssurX?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 25
Verified Reviewer
Overall rating
  • Industry: Biotechnology
  • Company size: 10,000+ Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

An agile solution that doesn't compromise on compliance.

Reviewed on 2018/10/18

We are a global drug company with manufacturing sites all over the world. Due to nature of the data...

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.

Kevin
Overall rating
  • Industry: Medical Devices
  • Company size: 501–1,000 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

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

Reviewed on 2020/06/22

We are hoping to transform our whole QMS with AssurX. Everything is currently manual on paper...

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.

Reasons for Switching to 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.

Response from AssurX

AssurX has since updated its graphics for charts and KPI metrics.

LuAnn
Overall rating
  • Industry: Electrical/Electronic Manufacturing
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 8.0 /10

Ease of program

Reviewed on 2020/06/11

setting up new modules

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.

William
Overall rating
  • Industry: Utilities
  • Company size: 501–1,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 10.0 /10

Powerful Flexable Tool

Reviewed on 2020/06/16

My utility first developed a manual system built around AssurX to identify and trigger event driven...

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.

Paul
Overall rating
  • Industry: Computer Hardware
  • Company size: 51–200 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support
  • Likelihood to recommend 8.0 /10

AssurX Review

Reviewed on 2021/01/10

We are using for corrective and preventative actions, manufacturing and supplier non-conforming...

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.

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.

Showing 5 reviews of 25 Read all reviews

AssurX FAQs

Below are some frequently asked questions for AssurX.

AssurX offers the following pricing plans:

  • Free Trial: Not Available

Contact AssurX for pricing information.

AssurX has the following typical customers:

51–200, 201–500, 501–1,000, 1,001–5,000

AssurX supports the following languages:

English

AssurX supports the following devices:

Android (Mobile), iPhone (Mobile), iPad (Mobile)

AssurX integrates with the following applications:

Agile CRM, Blue Link ERP, Dynamics 365 Business Central, Microsoft 365, Microsoft Azure, NetSuite, Oracle CRM On Demand, Oracle Cloud Infrastructure (OCI), SAP Analytics Cloud, SAP Business ByDesign, SAP Business One, SAP Customer Experience, Salesforce Platform

AssurX offers the following support options:

Email/Help Desk, Phone Support, Chat

Related categories

See all software categories found for AssurX.