Who is this service for?

Highly-regulated industries including Pharmaceutical, Biotechnology, Medical Device, High Tech Manufacturing, Energy & Utilities, Food & Beverage, and others.

About AssurX

Simplify quality management and regulatory compliance with one versatile system. The AssurX platform is a software system that automates quality and compliance to help companies streamline workflow, control risk and better manage their operations. Begin with the functionality you need now, then implement what you like as you're ready. No other system is easier to deploy, configure, use and modify. Companies of every size and industry rely on AssurX.

Average rating 4.5/5

Total score
4.5
“Ease of use
4.1
User support
4.7
Features
4.4

Product details

Starting price:

1usd / per month
more about prices

Desktop & Mobile Platforms:

Mac

Windows

Linux

App - Android

App - IOS

Cloud, SaaS, Internet

Training:

Documentation

Online

Support:

Working hours

Online

Software Developer

AssurX
http://www.assurx.com
Set up in 1993
United States

Features

Audit Management
Change Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Coding & Control
Equipment Management
Incident Management
ISO Standards Management
Maintenance Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis

Supplier Quality Control
Training Management

Alternatives AssurX


L
Lou P.

«QMS CATSWEb processes»

Usability

Support

Features

4

Overall rating

Benefits:

It is flexible to manage multiple quality processes.

Drawbacks:

The programming options are limited and integration with other systems is clunky.

In sum:

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.

September 28, 2021
Feedback source: the Internet
D
David V.

«AssurX/CATSWeb - Great Harmonized QMS»

Usability

Support

Features

5

Overall rating

In sum:

Comments - CATSWeb is a highly configurable enterprise Quality Management System (QMS) which allows us to bring all of our Quality System processes under one enterprise solution. We had 4 different systems in the past, but are moving to a single system for ease of user experience, process management and reporting metrics. I have been fortunate to configure CATSWeb at several companies and have always found the system very user friendly. Recommendations It is important to understand your processes before trying to automate them. Bad processes end up making for bad automated processes. Having someone within the organization who understands the system will greatly reduce setup.

September 5, 2021
Feedback source: the Internet
K
Kirsten E.

«Worked Well»

Usability

Support

Features

4

Overall rating

Benefits:

It did store all our documentation in one area.

Drawbacks:

There wasn't much protection on these documents. For instance anyone can download a native version in word and type what they wanted in there.

September 4, 2021
Feedback source: the Internet
W
Wincy F.

«Highly configurable with top notch professional services»

Usability

Support

Features

5

Overall rating

Benefits:

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

Drawbacks:

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

In sum:

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.

September 3, 2021
Feedback source: the Internet
I
Irene M.

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

Usability

Support

Features

5

Overall rating

Benefits:

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.

August 11, 2021
Feedback source: the Internet
M
Michael P.

«CATSWeb Evaluation»

Usability

Support

Features

4

Overall rating

Benefits:

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.

Drawbacks:

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.

In sum:

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.

July 24, 2021
Feedback source: the Internet
H
Heidi M.

«AssurX»

Usability

Support

Features

2

Overall rating

Benefits:

The ease of management of the users within the system.

Drawbacks:

There was not a good flow, and had to click so many times in order to get where you wanted. Also the searching was terrible.

July 18, 2021
Feedback source: the Internet
W
William T.

«Powerful Flexable Tool»

Usability

Support

Features

5

Overall rating

Benefits:

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.

Drawbacks:

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.

In sum:

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.

June 28, 2021
Feedback source: the Internet
V
Verified Reviewer

«An agile solution that doesn't compromise on compliance.»

Usability

Support

Features

5

Overall rating

Benefits:

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.

Drawbacks:

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.

In sum:

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.

June 5, 2021
Feedback source: the Internet
S
Stephanie M.

«Flexibity»

Usability

Support

Features

5

Overall rating

Benefits:

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

Drawbacks:

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

May 21, 2021
Feedback source: the Internet