AssurX Quality Management System Software

4.60 / 5 (10)

Our advisors have recommended this product 1 time in the last 30 days

About AssurX Quality Management System

The AssurX QMS software platform is a configurable system of workflows that can connect unlimited processes to create a closed-loop quality system. Built for regulated industries with stringent compliance requirements, AssurX enables enterprises to create quality systems aligned with regulations and standards (FDA/CGMP, EMA, SEMI, ISO, etc.), to minimize risk exposure, proactively resolve deviations and non-compliance issues, protect data integrity and manage change. Quality and compliance issues and status are visible through built-in dashboards with data analysis and reporting. Electronic report submissions adhere to regulatory guidance.

AssurX creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the extent re...


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Supported Operating System(s):

Mac OS, Linux, Web browser (OS agnostic), Windows 10

22 Reviews of AssurX Quality Management System

Average User Ratings

Overall

4.60 / 5 stars

Ease-of-use

4.5

Value for money

4.5

Customer support

5.0

Functionality

4.5

Ratings Snapshot

5 stars

(7)

7

4 stars

(2)

2

3 stars

(1)

1

2 stars

(0)

0

1 stars

(0)

0

Likelihood to Recommend

Not likely

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Showing 1 - 20 of 22 results

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June 2020

Kevin from Advanced Medical Solutions

Company Size: 501-1,000 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

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.

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 Quality Management System

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.

October 2018

Anonymous

Verified Reviewer

Company Size: 10,000+ employees

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

October 2018

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.

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.

June 2020

William from PowerSouth Energy Cooperatice

Company Size: 501-1,000 employees

Industry: Utilities

Time Used: More than 2 years

Review Source


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

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.

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 Quality Management System

Competitive price, and superior Configuration and interface.

June 2020

LuAnn from Comark LLC

Company Size: 51-200 employees

Industry: Electrical/Electronic Manufacturing

Time Used: More than 2 years

Review Source


Ease-of-use

3.0

Value for money

3.0

Customer support

3.0

Functionality

4.0

June 2020

Ease of program

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.

Reasons for Choosing AssurX Quality Management System

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

June 2020

Ron from Bausch & Lomb

Company Size: 10,000+ employees

Industry: Medical Devices

Time Used: More than 2 years

Review Source


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

AssurX CATSWeb QMS application has stood the test of time

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.

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 Quality Management System

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

June 2020

Robin from Advanced Medical Solutions Ltd

Company Size: 1,001-5,000 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

Excellent Product and service

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 Quality Management System

The product does the job we need it to do at a price point which makes a very compelling business case.

January 2018

Bryan from ImmunoGen

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

3.0

Value for money

4.0

Customer support

5.0

Functionality

4.0

January 2018

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

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.

June 2020

Lou from Lantheus Medical Imaging

Company Size: 501-1,000 employees

Industry: Pharmaceuticals

Time Used: More than 2 years

Review Source


Ease-of-use

3.0

Value for money

5.0

Customer support

5.0

Functionality

3.0

June 2020

QMS CATSWEb processes

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.

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 Quality Management System

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

June 2020

Wincy from Takeda Pharmaceuticals

Company Size: 10,000+ employees

Industry: Pharmaceuticals

Time Used: More than 2 years

Review Source


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

Highly configurable with top notch professional services

AssurX is a company focusing on delivering a platform that allows customers to tailor the solution through configuration that fits their business process and requirements. Their validation package is comprehensive providing another benefits to customers for utilization. Ease of use and configurability of this system enable accelerated delivery and implementation which is vital in the current Agile development.

Pros

The software provides excellent configuration capability. It provides high flexibility to support process requirements.

Cons

Reporting features can be more robust but in the digital era users should focus on data query capability not reporting.

December 2017

Deb from VELCO

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2017

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

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.

June 2020

Kathleen from Canadian Hospital Specialties

Company Size: 201-500 employees

Industry: Medical Devices

Time Used: More than 2 years

Review Source


Ease-of-use

4.0

Value for money

4.0

Customer support

5.0

Functionality

3.0

June 2020

AssurX - gets the job done

Pros

Workflows are very customizable and professional service is very responsive and helpful

Cons

There are some limitations regarding proxy assignment and group training.

June 2020

Sébastien from RECIPHARM

Company Size: 201-500 employees

Industry: Pharmaceuticals

Time Used: Less than 12 months

Review Source


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

Catsweb review

We use Catsweb for more than 10 years to manage our quality process, as document & training management system. We are very satisfied with this software solution

Pros

This software solution provides a lot of functionnalities to configure and manage quality process. From an IT point of view, this system is easy to implement and maintain.

Cons

No issue or improvement to request at this time.

June 2020

Stephanie from IT

Company Size: 10,000+ employees

Industry: Pharmaceuticals

Time Used: More than 2 years

Review Source


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

June 2020

Flexibity

Pros

the flexibility to configure to the business process with out of the box tools.

Cons

Some of our novice users struggle to navigate between records. But the new UI helps to overcome this with a breadcrumb trail.

January 2018

Allen from Sechrist Industries, Inc.

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

5.0

Functionality

5.0

January 2018

System is very expandable and customizable

Pros

I like the customization and the fact that I can link all my SQL systems to do advanced features and functions.

Cons

I wish we had more fields on both actions and subtasks. Error message is tough at times because I cannot tell what I am missing or what is firing off and when the crash occurs. When in an Event Hook - not being able to jump directly to the assigned Data Link is a time consuming con.

July 2016

Michael from Eversource, Inc.

Company Size: 10,000+ employees

Industry: Utilities

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

3.0

Value for money

4.0

Customer support

4.0

Functionality

4.0

July 2016

CATSWeb Evaluation

I used CATSWeb for NERC Standard compliance tracking and found that I had to rely on an internal CATSWeb experts who guided me through the process. It was not always intuitive how to use the interface and how to set up reviews.

Pros

The system is comprehensive and has some nice features like automatically loading NERC Standards. It has a nice workflow characteristic that routes reviews to assigned individuals for signoff.

Cons

Queries and reports can be cumbersome to set up, but after they've been set up they can be saved for future use, which is a nice feature. Learning how to use the system takes a lot of time.

January 2018

Jonel from Johnson & Johnson Vision, Surgical

Company Size: 1,001-5,000 employees

Industry: Medical Devices

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

January 2018

Great customer support and value.

The software supports our whole complaint handling system including eMDR submissions.

Pros

A highly configurable system that you can customize according to your needs. Great record audit trail. The ability to use the system for eMDR submission was a plus.

Cons

I hope they add a feature to track history for the configuration similar to the audit trail available for the records. This would be great for a highly customizable system to be able to trace changes to the system changes.

January 2018

Tom from Standard Textile

Company Size: 1,001-5,000 employees

Industry: Textiles

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

January 2018

We have been very pleased with the ease of use and ability to configure to our needs.

Simplicity, flexibility, and an all-in-one suite. The one thing that I wish was better already has a remedy in the works (version 8). The current graphing capability is not as flexible or varied as I would like. I would like it to be similar to the capability and flexibility that you can get out of Excel. Hopefully, Version 8 will solve this.

Pros

I like its flexibility and ease of use. With the guidance of their professional services, I have quickly gained enough knowledge to be effective (and slightly dangerous) at tweaking the system. It allows you many options, but it is not to complex. The support is quick to respond and talks me thru the methodology so that I can make similar changes later without needing support.

January 2018

Paula from NxStage Medical, Inc.

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

January 2018

The team at AssurX was fantastic throughout the design, implementation, and launch of CATSWeb

Pros

The customization ability. The ability to mold the system and, with relative ease, make what exactly what you want sets it apart from other systems.

Cons

We use a hosted solution. Limitations on the hosted systems (i.e. not being able to pull data from CATSWeb to other databases such as Birst) has been a challenge for our organization

January 2018

Maxim from Takeda Pharmaceuticals

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

January 2018

Overall it has been a great experience adopting AssurX CATSWeb as our QMS globally.

Ability to deliver a single solution to harmonize and standardize Quality Management System globally.

Pros

Ability to configure the software based on user and functional requirements, and integrations with other boundary systems.

Cons

We would like to obtain more clear roadmap of their products and service offering and release communicated through various channels.

January 2018

Irene from Philips

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

January 2018

Excellent software tool, and the customer service and technical expertise is phenomenal!

Pros

Highly configurable, great reporting functionality, great value for the product ' services received. The system can be configured to implement any workflow/functionality that you need to align with your quality system processes and forms.