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.

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.

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.

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.

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.

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.

setting up new modules

the ease for queries. we can have this build to meet our needs.

Better merge with company ERP system. should have more training once up and running admins should have the know ow to make format changes.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The ability to quickly develop, validate and deploy any work flow process using internal developers.

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.

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.

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.

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.

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.

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.

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.

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.

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.

It is flexible to manage multiple quality processes.

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

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

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.

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.

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

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.

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.

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

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.

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.

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

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

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

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.

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

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

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.

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

There are some limitations regarding proxy assignment and group training.

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

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.

No issue or improvement to request at this time.

The software is highly configurable and can be adapted to any workflow we have. We can use it for quality management system processes and non-quality processes. The audit trail is the best audit trail I've seen in any QMS.

The user interface can be non-intuitive for the novice or occasional user and additional training is often required to help them navigate the workflow.

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

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

It did store all our documentation in one area.

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.

The ease of management of the users within the system.

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.

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.