About AssurX Quality Management System

AssurX Quality Management System is a cloud-based solution designed to help the manufacturing industry streamline corrective and preventive actions (CAPA), document lifecycle, compliance audits and risk assessment. Key features include defect tracking, supplier quality control, training management, document control and maintenance management.

Teams using AssurX Quality Management System can automatically send notifications as per approvals, escalations and routing for various processes. The platform helps users accelerate response to issues prompted by defects, unexpected failures and other nonconformances. Additionally, organizations can track/monitor the performance of products and operations throughout the entire lifecycle to facilitate best practices...


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Supported Operating System(s):

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

13 Reviews of AssurX Quality Management System

Average User Ratings

Overall

4.69 / 5 stars

Ease-of-use

4.0

Value for money

4.5

Customer support

5.0

Functionality

4.5

Ratings Snapshot

5 stars

(9)

9

4 stars

(4)

4

3 stars

(0)

0

2 stars

(0)

0

1 stars

(0)

0

Likelihood to Recommend

Not likely

Very likely

Showing 1 - 5 of 13 results

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 weve been using CATSWeb, there hasnt 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.

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.

January 2018

Ron from Valeant Pharmaceuticals

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

4.0

Functionality

4.0

January 2018

CATSWeb provides tremendous flexibility in the development and maintenance of our global QMS

Pros

The ability to develop / configure any defined workflow process. The use of concurrent licensing. The ability to easily export our data for use with our Business Intelligence application QlikView. The ability to interface with other software applications like, Salesforce.com, Peoplesoft, Documentum and Kintana. The level of technical support provided by the team at AssurX has been very good, they are professional and are very responsive to questions or concerns and have been able to address any technical issues we have experienced quickly and effectively.

Cons

Earlier versions of the software do not handle double byte characters, however their upcoming software release is said to address this need. We are looking forward to this new capability.

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.

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.